Senior Manufacturing & Process Design Engineer

Location: Meath| Permanent | Full-time

Senior Manufacturing & Process Design Engineer required for a growing medical device manufacturer operating within an ISO 13485-regulated environment.

This is a hands on engineering role with responsibility for developing and improving manufacturing processes, supporting NPI and design transfer, introducing equipment and tooling, and delivering process validation and continuous improvement projects.

Key Responsibilities

• Develop and optimise manufacturing processes for new and existing medical devices.

• Support NPI, design transfer and manufacturing scale-up.

• Specify, install and commission equipment, fixtures, tooling and test systems.

• Develop and execute IQ, OQ and PQ/process validation activities.

• Prepare process specifications, work instructions, risk assessments and validation documentation.

• Lead investigations into process issues, scrap, rework and non-conformances.

• Deliver improvements in quality, productivity, capacity, cost and safety.

• Identify opportunities for automation, Lean and continuous improvement.

• Work closely with Quality, Operations, Supply Chain and international engineering teams.

About You

• Degree in Mechanical, Manufacturing, Biomedical, Polymer, Industrial Engineering or a related discipline.

• Ideally 5+ years' experience in medical device or another regulated manufacturing environment.

• Strong manufacturing/process development and process improvement experience.

• Experience with process or equipment validation, ideally IQ/OQ/PQ.

• Experience with NPI, design transfer or equipment introduction.

• Working knowledge of ISO 13485, risk management and change control.

• Strong problem-solving and root cause analysis skills.

• Lean, Six Sigma or Kaizen experience is advantageous.

• Hands on, organised and self motivated with the ability to take ownership and drive projects forward.

This role would suit an experienced Manufacturing or Process Engineer ready to take the next step, as well as an established Senior Engineer looking for greater responsibility and variety.

Apply now to find out more.