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 recent 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 obje