Location: East Cork
Job Type: Contract
Location: €55,000 – €70,000 / year
About the job
Role Overview
Join a specialist manufacturing team that delivers one off, patient specific implants. You will drive validation and qualification for process that interfaces with upstream and downstream steps. This is a 12 month contract with potential to extend, the broader programme runs through 2027 for the right person.
You will be part of a 30 plus cross functional engineering group that includes process owners, subject matter experts, and mechanical engineers.
Key Responsibilities
- Plan and execute validation activities: Equipment Qualification, Process Characterisation, and Performance Qualification.
- Contribute to user requirements and protocol development, then complete analysis using appropriate statistical methods.
- Generate and maintain compliant documentation: URS, risk assessments, protocols, reports, traceability.
- Support day to day readiness for manufacture, non conformance resolution, and continuous improvement.
- Work hands on with a solvent based cleaning process using ultrasonic baths, with touchpoints to CNC and sterilisation steps.
- Collaborate with stakeholders across quality, manufacturing, and engineering to ensure safe and timely product release.
Experience Required
- 2 to 4 years’ experience in medical devices, not a graduate role.
- Proven exposure to validation workstreams: EQ, Characterisation, PQ, URS, statistical analysis.
- Experience with cleaning process validation is a strong advantage, not essential.
- Sterilisation knowledge is beneficial.
Qualifications
- Degree in Mechanical Engineering is preferred, other relevant engineering disciplines considered.