Product Development Engineer

JR United Kingdom; Dunfermline; On-site; GBP 40,000 - 60,000; Full time

Job summary

An innovative MedTech company is seeking an experienced engineer to lead post-design development for medical devices. The role involves managing all phases from design to market release, focusing on patient safety and usability, while ensuring compliance with ISO 13485 standards. This is a key opportunity for professionals motivated to enhance medical outcomes.

Qualifications

• 5+ years in medical device R&D or development.
• Ownership of post-design activities.
• Strong experience under ISO 13485.

Responsibilities

• Leading post-design development across usability and risk analysis.
• Driving design verification and validation strategies.
• Managing smooth transfer to manufacture.

Skills

Usability Engineering

Human Factors

Risk Management

V&V Processes

Education

Engineering or Scientific Degree

Job description

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Client:

Cure Talent

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

06.06.2025

Expiry Date:

21.07.2025

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Job Description:

Cure Talent are delighted to be partnering with an innovative MedTech company dedicated to transforming patient safety, monitoring and outcomes in invasive vascular and surgical care.

We’re seeking an experienced engineer with deep working knowledge of ISO 13485 and proven capability across the post-design, full product lifecycle. You’ll be the technical lead, taking products from design through to successful manufacture and market release, managing all critical phases: Usability, Risk, V&V, Documentation, and Transfer to Manufacture.

Key Responsibilities Include:

• Leading post-design development across usability, human factors, and risk analysis incl. FMEA
• Driving design verification and validation, planning and executing V&V strategies
• Managing smooth transfer to manufacture and serving as liaison with CMOs
• Defining and maintaining BoMs, materials, and supporting design for manufacture principles

What We’re Looking For:

• 5+ years in medical device R&D or development, with ownership of post-design activities and an engineering or scientific degree
• Strong experience working under ISO 13485, with full DHF and regulatory documentation responsibility
• Skilled in usability engineering, human factors, and risk management e.g. FMEA
• Solid understanding of V&V processes and manufacturing transfer

If you’re eager to be at the forefront of medical device development and work with a company that prioritizes patient outcomes, we’d love to hear from you!