A leading Medical Device company is in immediate need of a Biocompatibility Engineer to support their operations in San Clemente, CA for an 8-month project. This consultant will need to be onsite for at least 3 days during the week.
The Biocompatibility Engineer will help to ensure patient safety by supporting evaluations of medical devices, materials, and processes. The consultant will need to work with cross-functional teams to apply global regulatory standards like ISO 10993 and will provide guidance throughout the product development lifecycle, interpret regulatory requirements, and support the overall biocompatibility strategy. The project will also be focused on gap analysis and recommending risk mitigation strategies.
Top Requirements and Duties:
- BS degree minimum
- 2+ years of medical device industry experience
- Understanding of ISO 10993 standards, biomaterials, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology
- Proficient in MS Office and excellent written and verbal communication skills
- Conduct biocompatibility assessments and evaluations in accordance with biological evaluation standards and regulatory requirements
- Analyze biocompatibility test results
- Assist with regulatory submissions and address biological safety concerns in design meeting
- Contribute to the development and implementation of biocompatibility
- Conduct sample preparation feasibility testing
- Write biological evaluation plans, reports, and other biocompatibility-related material
- Maintain effective communication with all levels of employees, customers, contractors, and vendors
