Advanced Manufacturing Lead
7 days ago
Become a part of BIOTRONIK SE & Co's global workforce and contribute to the development of cutting-edge medical devices.
About the RoleThis is an exciting opportunity for a Senior Advanced Manufacturing Engineer to join our team in Singapore. As a key member of our production engineering group, you will play a crucial role in ensuring the successful transfer and implementation of new manufacturing processes at our APM II site.
Responsibilities- Partner with project managers to lead cross-site, multi-departmental project core teams to set up and integrate new manufacturing processes into the Singapore manufacturing plant.
- Support product development projects by providing inputs for Design For Manufacturing (DFM).
- Initiate Change Requests (CR) for projects and source competent suppliers using appropriate tools such as Supplier Evaluation Matrix.
- Conceptualize, document, and procure fixtures, tools, and equipment for serial manufacturing.
- Coordinate infrastructure readiness, including floor plan, facility, and media preparation.
Additionally, you will work with project teams to establish Device Master Records (DMR) and ensure all systems, including SAP, MES, and middleware, are set up for long-term stable production. You will also be responsible for planning and executing validation plans (PPFU, IQ, OQ, PQ) for equipment and processes within project scope.
RequirementsTo succeed in this role, you will need a strong technical background in injection molding processing, tooling, equipment, manufacturing, and quality. Prior experience in both Liquid Silicon Rubber (LSR) and thermoplastic (e.g., PEEK) is preferable. Familiarity with ISO13485 and GMP is also essential.
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