Senior Biocompatibility Specialist

Stryker — Gurugram, India

Work Flexibility: Hybrid What you will do: Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests. And support product transfers to other plants/facilities. Partners with cross-functional project team members to define evaluation / verification strategies of medical devices and review, evaluate, interpret, and apply internal and external guidance documents as they relate to biocompatibility. Identify and analyze materials, design, and process challenges to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety. Responsible for identifying critical process factors and their effects on biological safety. Develop technically sound test campaigns (i.e. biocompatibility and chemical testing)., protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team, test laboratories, and suppliers; develop and execute project plans to include definition of scope, timelines, critical path management, resources, and budget as they relate to biocompatibility. Review/approve nonconforming material and system documentation; product and process change control documentation and specifications and interface with key business partners and represent biocompatibility team on new product development teams. Make positive contributions, recommend approaches, and support updating / developing internal procedures that comply with applicable global regulatory requirements. Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects. Participate in the development and improvement of the manufacturing processes for existing and new products and actively participate on teams to support new product development activities. Support design verification and validation test requirements that ensure appropriate objective evidence is ava

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