Senior Product Development Engineer

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