Senior Design Assurance Engineer

Life Science Recruitment; Burgenland; Hybrid; EUR 50 000 - 90 000; Vollzeit

Zusammenfassung

An exciting opportunity awaits with a forward-thinking medical device company, seeking a Senior Design Assurance Engineer. This role involves ensuring compliance with critical medical device regulations while supporting the development of innovative stent platforms. You will collaborate with a dynamic team, focusing on risk management and design validation to enhance products for treating peripheral arterial diseases. This company fosters a culture of innovation and respect, providing an environment where your contributions will significantly impact the growth of cutting-edge medical solutions. If you're ready to advance your career in a supportive and engaging setting, this position is perfect for you.

Leistungen

Competitive salary

10% bonus

Full family healthcare

Flexible working hours

Pension contribution

Qualifikationen

• 4+ years experience in medical device design assurance, particularly with stents.
• Strong understanding of ISO standards and FDA regulations.

Aufgaben

• Ensure compliance with medical device regulations and quality systems.
• Lead risk management activities and develop design verification plans.

Kenntnisse

Design Assurance

Risk Management

Human Factors Engineering

Validation and Verification

Compliance with FDA Regulations

Ausbildung

Degree in Engineering

Degree in Science

Tools

ISO 13485

ISO 14971

FDA Quality System Regulations

Jobbeschreibung

Job Title: Senior Design Assurance Engineer

Location: Parkmore Business Park, Galway (Hybrid working 2 days a week on site)

Benefits: Competitive salary, 10% bonus, Hybrid working, Full family healthcare, flexible working hours and pension contribution. Also an excellent opportunity to build your career with an exciting Medical Device company going through a growth phase.

Company: My client is a rapidly growing medical device company offering a highly differentiated solution in SFA interventions. Their culture of innovation helps each individual develop both professionally and personally, and their culture of respect means that they all work in a collaborative, empowering, and exciting environment.

Role: Reporting to the Design Assurance Director, the Senior Design Assurance Engineer will work as part of the team in supporting the sustainment of commercialized stent platforms and in the development of new stent platforms, focusing predominantly on projects to introduce or improve products for the treatment of peripheral arterial disease states. This is a fantastic opportunity to work as part of a supportive, collaborative team in the new state-of-the-art facility in Galway.

Job Requirements:

• Work within the quality system to ensure compliance with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, MDR 2002 (UK), FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971, and Japanese Ministerial Ordinance # 169.
• Support the development/evolution of the Veryan Design Control, Risk Management, and associated systems (e.g., labelling/packaging).
• Provide Design Assurance input to R&D project teams for designated projects.
• Lead the risk management activities for assigned projects in line with ISO 14971 and Veryan procedures.
• Develop and maintain design verification and validation plans, protocols, and reports for design changes.
• Support the preparation and delivery of Design Transfer to Commercial Reviews and associated checklists.
• Design, develop, and validate test methods as required to support development programs.
• Lead Human Factors / Usability Engineering activities and maintain Usability Engineering File for assigned projects.
• (Where applicable) Support the execution of non-clinical studies at third party facilities, in conjunction with the R&D department.
• Execute/review gap analysis to standards, ASTM and other associated documents, and assess impact to product DHFs.
• Coaching and mentoring of colleagues and more junior members of the team.

Education & Training:

• A degree level qualification in Engineering, Science, or related field is required.

Experience:

• Upwards of 4 years’ relevant experience in the medical device industry, preferably with Stent or class III device design assurance experience.
• An understanding of ISO 13485, ISO 14971, and FDA QSRs is a prerequisite.
• Familiarity with statistics, validation, and physical testing is required.

Does this sound like your next career move? To apply and for more info, forward your application to the link provided or contact me at 087 0612325 or [e-mail].