Senior Manufacturing Quality Engineer

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Principal Technical Consultant | Science & Engineering RecruitmentHiring top contractors across Europe

WHO ARE WE?

A start-up based in Ireland and Germany developing cutting edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to create new hardware, software and data science technologies.

The position, based in Ireland and reporting to the Quality Manager. This position is a hybrid role, with 3 days required on site in Galway. The Senior Manufacturing Quality Engineer is responsible for ensuring that medical device design and development processes comply with applicable regulatory and industry standards, including ISO 13485, ISO 62304, ISO 62366, ISO 60601-1, ISO 60601-2-37, ISO 14971, and medical device labeling requirements. This role will work cross-functionally with R&D, Regulatory Affairs, and Manufacturing to ensure that product design meets both customer needs and regulatory expectations. In addition, this role with support the Quality department in the areas of internal audit, CAPA, non-conformances and document control.

Your role will be

• Provide quality engineering expertise to support design and development activities in compliance with ISO 13485 and FDA QSR (21 CFR Part 820) requirements.
• Support risk management activities per ISO 14971, including hazard analysis, FMEA, and risk-benefit analysis.
• Ensure compliance with software lifecycle processes per ISO 62304, collaborating with software engineering teams to establish and maintain software validation and verification processes.
• Oversee compliance with usability engineering requirements per ISO 62366, working with human factors specialists and user experience teams.
• Ensure that electrical and mechanical designs comply with ISO 60601-1 (general safety) and ISO 60601-2-37 (specific requirements for ultrasonic medical devices, if applicable).
• Support the development and review of medical device labelling, ensuring compliance with international regulations and standards.
• Lead design reviews and provide quality input throughout product development lifecycle.
• Develop and execute test method validation (V&V) plans, ensuring compliance with regulatory requirements.
• Develop and execute design verification and validation (V&V) plans, ensuring compliance with regulatory requirements.
• Develop and execute computer system validation (V&V) plans, ensuring compliance with regulatory requirements.
• Support root cause analysis (RCA) and failure mode analysis (FMEA) to identify production issues and implement corrective and preventive actions (CAPA)
• Collaborate with Regulatory Affairs to support regulatory submissions, providing necessary documentation and justifications.
• Sit on Change Control Board as Design Quality representative
• Serve as a quality representative in audits and inspections conducted by regulatory bodies, such as the FDA, ISO auditors, and notified bodies.
• Ensure compliance with cybersecurity requirements for medical devices in accordance with FDA guidance and EU regulations.
• Support the integration and validation of Artificial Intelligence (AI) applications in medical devices, ensuring adherence to evolving regulatory expectations and risk management strategies.
• Support Quality Department in areas of internal audit, CAPA, non-conformances and document control

What you offer

• Bachelor's degree in Engineering, Quality, or a related field
• Minimum of 4 years of experience in medical device design quality engineering
• Strong knowledge of ISO 13485, ISO 62304, ISO 62366, ISO 60601-1, ISO 60601-2-37, ISO 14971, and medical device labeling regulations.
• Experience working with FDA QSR (21 CFR Part 820) and international regulatory requirements.
• Proven experience with risk management tools such as FMEA, Fault Tree Analysis, and Hazard Analysis.
• Hands-on experience with design verification and validation (V&V) processes.
• Familiarity with product lifecycle management (PLM) systems and document control processes.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to influence others and drive quality initiatives across departments, and organizations
• Excellent communication and teamwork abilities, with experience in cross-functional collaboration.
• Demonstrated success in driving continuous improvement initiatives
• Strong project management skills and ability to lead multiple initiatives simultaneously
• Experience in Internal Audits preferable
• Willingness to travel up to 25%

WHAT WE OFFER

• Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
• Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
• A learning environment where you can extend and build upon your skills and interests.
• Flexible working environment and an international culture as well as offices in Germany and Ireland.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionEngineering, Manufacturing, and Quality Assurance
• IndustriesMedical Equipment Manufacturing

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