Lediga job som Medicinsk ingenjör

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

Take the lead in shaping the future of surgical tables, combining hands-on product development with leadership of a skilled R&D team to deliver innovative solutions for operating rooms worldwide. Ready to make an impact? Join us.

Stille AB is a Swedish medical device company with a long heritage in precision-engineered surgical instruments and operating tables, sold globally through leading distribution partners including GE HealthCare, Ziehm, Philips and Siemens Healthineers. Our Surgical Tables business unit designs and manufactures advanced OR and hybrid imaging tables — including the imagiQ3 platform with True Free Float® technology and the Medstone range — used in hospitals and imaging suites worldwide. Stille’s vision is to empower surgical excellence through products that enable the highest standards of care, fulfilling our promise: “Surgical Perfection. For Life.”

The Role

We are looking for an R&D Manager to lead the product life cycle management of our existing portfolio as well as the development of our next generation of surgical table platforms This is a hands-on role at the intersection of electromechanical engineering, project management and product cost strategy — owning both the technical integrity of our electromechanical systems and the on-time, on-budget delivery of development programs, from concept through design transfer and regulatory submission.

You will lead a small R&D team while also being part of it yourself, with your own deliverables: balancing clinical performance, regulatory compliance, manufacturability and total cost of ownership.

Key Responsibilities

• Lead a small R&D team with senior employees, setting technical direction across electrical, electromechanical, mechanical and software workstreams for surgical table platforms.
• Own project management of development programs: scope, timeline, budget, risk and stage-gate governance
• Drive electrical and electromechanical architecture decisions for motion control, power systems, control electronics and human-machine interfaces used in imagiQ3, Medstone and future platforms.
• Ensure development activity meets medical device regulatory and quality requirements, including IEC 60601-1/-2-46, ISO 13485, ISO 14971 (risk management), EU MDR and FDA design control requirements.
• Champion design-for-cost and design-for-manufacture (DFM/DFA) thinking from the earliest concept stage, working closely with sourcing and operations to hit target cost and margin goals without compromising quality and clinical performance.
• Engage directly with suppliers and contract manufacturers on component selection, make-vs-buy decisions, and design trade-offs that affect cost, lead time and supply resilience.
• Partner with Product Management, Regulatory Affairs, Quality and Commercial teams to translate market and clinical requirements into robust, manufacturable, cost-competitive designs.
• Manage external partners, test houses and imaging partners on interface and integration requirements.
• Own technical documentation, design history files and verification/validation planning in support of regulatory submissions.
• Report R&D program status, risks and resource needs to senior management and the board as required.

What You Bring

• MSc in Electrical/Electronics Engineering, Mechatronics, Biomedical Engineering or a related discipline (or equivalent experience).
• Solid experience in electrical or electromechanical engineering for complex, regulated products — motion/motor control, power electronics, embedded systems or similar.
• Proven project/program management experience leading multidisciplinary engineering teams through the full development lifecycle, on time and on budget.
• A demonstrated cost-conscious engineering mindset — comfortable making design trade-offs against target cost, and working closely with commercial/sourcing/procurement or suppliers to get there.
• Strong communication skills in English and Swedish
• Genuine interest in both technology and people with strong communication and collaboration skills
• Solution-oriented and results-focused mindset building trust and lasting relationships with colleagues, partners and suppliers

Nice to Have

• Direct sourcing, procurement or supplier-development experience, particularly for mechatronic or electromechanical subassemblies.
• Experience with capital medical equipment (imaging, OR equipment, patient positioning systems)
• Familiarity with PLM/PDM tools, formal DFMEA/risk management processes, and Lean/Six Sigma cost-reduction methods.

What We Offer

The opportunity to hands-on lead technical development of market-leading surgical table platforms used in hospitals worldwide, within a company that combines the agility of a mid-size organization with the reach of global partnerships. You'll have direct visibility to commercial and board-level strategy and a real mandate to shape how we build products — technically and commercially.

At Stille, you will join a skilled and dedicated team where you can influence the future of our surgical table portfolio, contribute to meaningful innovation and grow professionally.

Location: Torshälla/Eskilstuna, Sweden

Reports to: VP Surgical Tables

Apply

Ready to make an impact, contribute to surgical perfection and be part of our exciting future within the Stille Group? If you match the profile above, we would be delighted to receive your application!

Please submit your CV and cover letter through our website: https://stillegroup.careers.haileyhr.app/ by October 4th at the latest.

We review applications and conduct interviews on an ongoing basis, and the position may therefore be filled before the closing date. We encourage you to apply as soon as possible.

Please note that we kindly decline contact from recruitment agencies and providers of recruitment services.