Innovative Product Developer
2 weeks ago
BD seeks a highly skilled R&D Tech Lead/Staff Engineer to join its team developing innovative medical products and technologies.
This senior role combines technical leadership, systems engineering, and regulatory compliance responsibilities, guiding cross-functional teams through the product lifecycle.
The successful candidate will shape product architecture, define system and sub-system requirements, ensure traceability and documentation for regulatory submissions, and mentor team members.
Main Responsibilities- System Design & Development: Lead system-level design and development for new and existing medical products, ensuring alignment with stakeholder needs.
- Requirements & Architecture: Define product architectures and translate stakeholder inputs into clear, traceable system requirements.
- Integration & Testing: Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.
- Technical Leadership: Provide mentorship and technical guidance to cross-functional teams, promoting engineering excellence.
- Documentation & Tools: Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements.
- Regulatory Compliance: Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and support FDA submissions through collaboration with quality and regulatory teams.
- Proven experience in leading technical project teams (HW, SW, UX, Systems) through the product lifecycle and phase-gate approach.
- Strong ability to lead large teams and communicate technical deliverables effectively.
- Experience in writing SOPs, guidance, and technical documentation.
- Bachelor's or Master's degree in Engineering, Systems Engineering, Biomedical Engineering, or related field.
- 5+ years of progressive experience as a senior/lead engineer in product development.
- Creative problem solver with the ability to resolve conflicting requirements and technical risks.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. For most roles, we require a minimum of 4 days of in-office presence per week.
BD is an Equal Opportunity Employer.
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