Engineer Senior, Drug Delivery Medical Device Biocompatibility (JP12000)
About The Position
3 Key Consulting is recruiting an Engineer Senior, Medical Device Biocompatibility for a consulting engagement with our direct client, a leading global biotechnology company. The ideal candidate for this role is a highly qualified professional with a Bachelor's degree in Science or Engineering and a minimum of 5 years of experience in the medical device industry. They possess a robust understanding of ISO 10993 biocompatibility standards, particularly parts 3, 4, 6, 7, 11, and 18, along with expertise in drug/device combination product design and development. With a solid grasp of Medical Device Regulations such as 21CRF820 and ISO 13485, excels in assessing and ensuring regulatory compliance. Excellent communication skills, both written and verbal, enable effective coordination with diverse stakeholders, and they exhibit strong problem-solving abilities. A team player with meticulous attention to detail, thrives in a deadline-driven environment, managing multiple projects while maintaining cross-functional alignment and presenting detailed information to governance bodies.
Requirements
- Bachelor's degree in Science or Engineering
- Minimum of 5 years of experience in the medical device industry
- Robust understanding of ISO 10993 biocompatibility standards, particularly parts 3, 4, 6, 7, 11, and 18
- Expertise in drug/device combination product design and development
- Solid grasp of Medical Device Regulations such as 21CRF820 and ISO 13485
- Excellent communication skills, both written and verbal
- Strong problem-solving abilities
- Meticulous attention to detail
- Ability to work in a deadline-driven environment
- Ability to manage multiple projects
- Ability to maintain cross-functional alignment
- Ability to present detailed information to governance bodies
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Responsibilities
- Detailed technical assessment of new/revised external requirements.
- Coordinate the assessment of changes to external requirements in collaboration with other Subject Matter Experts.
- Conduct document management system search for impacted records and disposition documents accordingly.
- Communicate outcome of technical decisions to all impacted platform and product teams.
- Coordinate with all impacted product teams to complete integration of requirement or justify no action and document it in Product Impact Assessment.
- Maintain cross-functional, platform and product alignment.
- Present summary of details and advice to Product External Requirement governance for a decision on Amgen’s position regarding a standard’s impact.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
