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.

When you can’t breathe, nothing else matters. That’s why a career at Breas Medical matters.

Our mission is to improve the quality of life and care of respiratory patients around the world through a personal commitment to innovation, quality and customer focus.

Are you our next Production Support Engineer?

Are you an engineer who enjoys solving technical challenges and turning ideas into reliable manufacturing solutions? You may already have experience in production or manufacturing engineering, or you may be at the beginning of your career with a relevant technical education and an interest in medical technology.

As a Production Support Engineer within R&D Sweden, you will play an important role in strengthening our production processes and supporting the introduction of new products and design changes. Working closely with Production, R&D, Quality and other cross-functional teams, you will help ensure that our products are manufactured safely, efficiently and in accordance with applicable quality and regulatory requirements.

This is an opportunity to combine hands-on production support with continuous improvement, technical problem-solving and long-term development in a highly regulated and meaningful industry.

The position is full-time, permanent and based on-site at Breas Medical’s headquarters in Mölnlycke, Sweden.

Main responsibilities

• Provide technical support to Production and help resolve manufacturing and quality-related issues.

• Lead or support design transfers, new product introductions and the implementation of design changes.

• Develop and improve manufacturing processes, methods, tooling, equipment and work instructions.

• Plan, perform and document process, verification and validation activities.

• Analyse production performance and contribute to improvements in product quality, production yield, safety and cost efficiency.

• Support Lean initiatives and collaborate with cross-functional teams to achieve shared goals.

About you

You are a curious and solutions-oriented engineer who enjoys turning technical challenges into practical improvements. You work in a structured way, with attention to quality, safety and documentation.

Collaboration comes naturally to you, and you are comfortable communicating with colleagues across different functions and areas of expertise. You have an open mindset, enjoy working close to production and are motivated by contributing to products and processes that make a meaningful difference.

To be successful in this role, we believe you bring some of the following experience and skills:

• A university degree in production engineering, medical engineering, mechanical engineering, electronics or another relevant technical field.

• Experience or a strong interest in production, manufacturing processes or medical technology.

• An understanding of mechanics, electronics and software, and how these areas interact within a product.

• Experience or knowledge of Design for Manufacturing, design transfer, verification, validation, tooling or process development.

• A structured approach to problem-solving and technical documentation.

• Good spoken and written Swedish and English.

Previous experience in production or manufacturing engineering is an advantage but not essential. We also welcome applications from recent graduates with a relevant educational background and an interest in developing within production engineering and medical technology.

Knowledge of regulatory requirements and standards for medical devices, such as ISO 13485, MDR, IEC 60601-1 or FDA requirements, is considered an advantage.

Be More with us

Join Breas and become part of a company where your experience, ideas and ambition can make a meaningful difference. Apply today and explore what it means to Be More.

Expected recruitment timeline

Applications will be reviewed continuously.

More about us

Founded in 1991 in Gothenburg, Sweden, Breas Medical is a global specialist in home mechanical ventilation and airway clearance, with a growing portfolio of sleep therapy solutions.

Our purpose is to help the world breathe better. We connect people throughout the respiratory journey by bringing together insights, innovation and care. Our solutions form a connected ecosystem that includes ventilation, airway clearance, interfaces, accessories, connectivity, services and clinical education, supporting patients, caregivers and healthcare professionals from therapy initiation to long-term care at home.

Headquartered in Sweden, Breas has more than 300 employees and subsidiaries across Europe, Asia-Pacific and the Americas. Together with our network of specialised distributors, we serve customers in over 40 countries worldwide.

Find out more:

• Breas Medical