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
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Plan and execute validation activities: Equipment Qualification, Process Characterisation, and Performance Qualification.
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Contribute to user requirements and protocol development, then complete analysis using appropriate statistical methods.
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Generate and maintain compliant documentation: URS, risk assessments, protocols, reports, traceability.
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Support day to day readiness for manufacture, non conformance resolution, and continuous improvement.
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Work hands on with a solvent based cleaning process using ultrasonic baths, with touchpoints to CNC and sterilisation steps.
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Collaborate with stakeholders across quality, manufacturing, and engineering to ensure safe and timely product release.
Experience Required
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2 to 4 years' experience in medical devices, not a graduate role.
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Proven exposure to validation workstreams: EQ, Characterisation, PQ, URS, statistical analysis.
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Experience with cleaning process validation is a strong advantage, not essential.
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Sterilisation knowledge is beneficial.
Qualifications
