Senior Process Engineer

About the Role

Senior Product Development / Process Engineer

About the Role

We are looking for an experienced Product Development / Process Engineer to support both product and process development for wire guides, nitinol self-expanding and plastic stents, delivery systems, and related minimally invasive devices. This role is built for someone who can operate as the onsite technical subject matter expert on their programs, comfortable in the lab, at home on the manufacturing floor and able to drive a technical issue to closure without waiting to be told how. You'll coordinate directly with client teams and direct an offshore engineering group that supports your analysis, documentation and execution work.

What You'll Do

• Lead product and process development for wire guides, nitinol self-expanding and plastic stents, delivery systems and related minimally invasive devices.
• Carry design and process changes from feasibility and design verification (DV) testing through process characterization, validation and manufacturing transfer.
• Develop and validate test methods that support design and process qualification.
• Apply design controls (DHF) and risk management practices consistently across the product lifecycle.
• Work hands on in the lab and on the manufacturing floor to troubleshoot issues and drive them to resolution.
• Serve as the onsite technical subject matter expert, coordinating directly with client teams on assigned programs.
• Direct an offshore engineering team, assigning and reviewing analysis, documentation, and execution support.

Experience & Skills Required

• 5+ years of hands-on medical device experience, ideally including wire guides, nitinol self-expanding or plastic stents, delivery systems, or other minimally invasive devices.
• Demonstrated experience spanning both product development and process development.
• Working knowledge of design controls (DHF), feasibility and DV testing, and test method development and validation.
• Experience with process characterisation, process validation and manufacturing transfer.
• Solid grounding in risk management and in managing design or process changes.
• Strong onsite technical execution, equally capable in the lab and in a manufacturing environment.