Manager - Equipment & Process Engineering
On-site · Mantes-la-Jolie, Île-de-France, France
Job Summary
Lead design, qualification and validation of manufacturing equipment, including procurement, installation and integration, ensuring ISO 13485 compliance. Develop prototyping capabilities and drive the transition from prototyping to industrial production. Define and execute site investment plans and Make-or-Buy strategies, while managing budgets and supplier/subcontractor partnerships. Collaborate with Process Validation to ensure full qualification (IQ/OQ/PQ) of equipment and processes, with robust traceability. Conduct process design activities aligned with engineering, quality, and regulatory requirements, contributing to feasibility studies and project timelines. Maintain a global, cross-functional approach in a multicultural environment and communicate effectively with stakeholders.
Required Qualifications
- 6-10 years of experience in equipment & process engineering within the medical device industry
- Masters or Bachelors in Engineering (Mechanical, Industrial or related field)
- Solid knowledge of ISO 13485 and regulated manufacturing environments
- Experience in equipment qualification (IQ/OQ/PQ) and process validation
- Fluent in English and French
- Strong communication and stakeholder management skills
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