Senior Engineer Biological Science
Senior Engineer Biological Science
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Job Description
Are you passionate about advancing medical technology and ensuring patient safety As a Senior Biocompatibility Engineer/Scientist you will play a pivotal role in developing cuttingedge osteosynthesis and arthroplasty products that improve lives worldwide.
In this role youll leverage your expertise in engineering microbiology and chemistry to lead biological safety verification and validation efforts. Youll collaborate with crossfunctional teams in R&D Quality Manufacturing and Regulatory Affairs while engaging with external regulatory bodies to drive stateoftheart medical devices and processes.
We offer a dynamic and innovative environment where your contributions will shape the safety and performance of nextgeneration medical implants. If youre looking for a career that combines scientific expertise with realworld impact this is your opportunity to lead innovate and make a difference in the medical device industry.
What you will do
- 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.
What you Must have
- Bachelor or Master of Science in Toxicology Immunology Chemistry Biology Biomedical Engineering or any related discipline
- 3 years of relevant professional experience with biocompatibility toxicological assessments of materials design or processes for medical devices.
- Technical leadership experience in a crossfunctional organizational setting.
- Fundamental understanding of the ISO 10993 Biocompatibility Regulation
- Critically review detailed scientific information communicate technical information in simpler terms and provide risk assessment
- Excellent communication skills: Fluency in English is mandatory
- Good to have Polish or French
Required Experience:
Senior IC
Employment Type
Full-Time
