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Job description
The Biocompatibility Engineer leads product safety and/or verification and validation test campaigns of osteosynthesis and arthroplasty products. Applies knowledge of engineering, microbiology, and chemistry to the evaluation of osteosynthesis and arthroplasty products, instrumentation, and auxiliary systems. Provide support and directions to other Scientists in the field of biocompatibility. Partner with cross-functional project teams to define evaluation / verification strategies of medical devices. Usually works with minimum of supervision, conferring with superior on unusual matters. Assignments are broad in nature, requiring originality and ingenuity.
- Prepare specifications for product safety and performance testing that are highly complex (e.g., create test plans and complex test protocols).
- Project planning of product safety and performance tests and test campaigns.
- Execute product safety and performance tests including documentation in test reports and approval thereof.
- Analyze and assess results gained utilizing adequate analytical means and methods according to guidelines.
- Manage external test projects (i.e. biocompatibility and chemical testing, cleaning validation, sterilization validation).
- Communicate, discuss, and conclude test and analysis results in cooperation with project teams.
- Consultation in terms of biocompatibility, cleaning, and sterilization validation questions.
- Biocompatibility SME for NC/CAPA process.
- Biocompatibility SME for change management process.
- Prepare, create, and maintain instructions and guidelines (standard operating procedures) as well as related labeling and collateral material for internal and external distribution.
- Communicate on best practices and methodologies and share those across sites with subject matter experts from other sites.
- Oversee subject matter expertise related international standardization (ISO, ASTM, FDA guidance, others) and implement requirements into guidelines.
- Functionally lead the work of intern, technicians, specialists, scientists and project engineers in the field of biocompatibility.