Process, Validation & Transfer Leader - Semi-Finished Barbed Suture
On-siteGroßostheim, Bavaria, Germany
Job Summary
Lead the technical and project leadership of the semi-finished barbed suture project from process development through validation (IQ/OQ/PQ) to operations transfer. Execute hands-on technical execution on the production floor, including equipment qualification, drying, and barrier packaging of moisture-sensitive absorbable materials. Manage schedule, budget, and resource allocation while coordinating design reviews, risk management, and capability studies with Quality Management. Ensure all validations follow strict planning protocols, with no reports issued without prior plans. Deliver approved project plans, complete barbing machine validation, and support production ramp-up by training staff and managing supplier coordination. This role serves as the second key element of the 2026–2027 plan, evolving toward product development for the ePTFE suture project upon completion of the current transfer in Q3 2027.
Required Qualifications
- Mechanical, biomedical, materials, or polymer engineering
- 3–6 years in medical device manufacturing or polymer processing
- demonstrated experience leading or coordinating projects (schedule, budget, multidisciplinary teams)
- process validation (IQ/OQ/PQ) experience involving validation packages the candidate has written
- Applied statistics: Process capability, sampling, and validation data analysis
- Strong German or English (B2+)
- Strong documentation discipline (planning before execution)
- hands-on presence on the production floor
- autonomy
- ability to keep a project on schedule, within budget, and at the required quality level without needing to be reminded
- product design/development foundation (prototypes, design inputs, testing)
Desired Qualifications
- Extrusion, spinning, or suture manufacturing
- experience with absorbable or moisture-sensitive materials (drying, barrier packaging)
- cleanroom experience
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