Senior Process Engineer

GIS Recruiter Ltd; Limerick; On-site; EUR 70,000 - 110,000; Full time

Job summary

GIS Recruiter Ltd is seeking an experienced Product Development / Process Engineer to support development for wire guides, nitinol self-expanding and plastic stents, delivery systems and related minimally invasive devices. This role requires hands-on lab work and factory floor activity, serving as the onsite technical SME on programs.

You will coordinate with client teams and offshore engineers, drive issues to closure, apply design controls and risk management, and ensure design verification

Qualifications

• 5–7+ years of hands-on medical device experience including wire guides, nitinol self expanding or plastic stents, delivery systems or similar devices.
• Experience spanning both product development and process development.
• Working knowledge of design controls (DHF), feasibility and DV testing, and test method development/validation.
• Experience with process characterisation, process validation and manufacturing transfer.
• Grounding in risk management and managing design or process changes.
• Strong onsite technical execution in both lab and manufacturing environments.
• Proven ability to coordinate across teams and drive technical issues to closure independently.

Responsibilities

• 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 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.

Skills

Medical device experience

Product development

Process development

Design controls

Risk management

Lab and manufacturing execution

Job description

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

• 5–7+ 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.
• Proven ability to coordinate across teams and drive technical issues to closure independently.

Where You'll Work

This position is based onsite in Limerick, Ireland. Expect regular time in the lab and manufacturing environment, direct coordination with client teams and day-to-day technical direction of an offshore engineering group