Staff Engineer
$135.5k - $216.8kBecton Dickinson & Co
Becton Dickinson seeks a Staff R&D Engineer to lead sustaining engineering initiatives for globally commercialized medical devices. The role involves evaluating product designs, developing technical solutions for compliance and market expansion, and collaborating across cross-functional teams to support long-term portfolio success.
Responsibilities
- Lead sustaining engineering projects supporting global product portfolios and design improvements
- Evaluate product designs against clinical, customer, regulatory, and business requirements
- Develop and implement technical solutions for global registrations, compliance, and product enhancements
- Conduct technical assessments for design changes, obsolescence, supplier changes, and risk mitigation
- Support regulatory submissions, technical files, risk analyses, and design documentation
Requirements
- Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related discipline with 8+ years experience
- Demonstrated experience with commercially released medical device lifecycle management and design changes
- Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971)
- Working knowledge of biocompatibility (ISO 10993), clinical considerations, and regulatory requirements
- Experience supporting global regulatory submissions and technical documentation
- Strong analytical, systems-thinking, and cross-functional influence capabilities
Vacancy posted 6 days ago
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