Staff Engineer
BD
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Benefits offered by this job
Job summary
BD is seeking a Staff R&D Engineer in the USA to lead sustaining engineering for medical devices, driving lifecycle management from design changes to global registrations. You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to ensure product continuity and market access.
Bring 8+ years in the medical device field, strong knowledge of Design Controls and ISO 14971, and proven ability to influence cross-functional teams while balancing regulatory,
Qualifications
- Bachelor's degree in Mechanical/Biomedical/Systems Engineering or related (8+ years in medical devices).
- Strong knowledge of Design Controls (21 CFR 820, ISO 13485) and ISO 14971 risk management.
- Experience supporting global regulatory submissions and technical documentation.
Responsibilities
- Lead sustaining engineering projects for global product portfolios.
- Evaluate designs against clinical, regulatory, and business requirements for improvements.
- Develop technical solutions supporting global registrations, market expansion, and compliance.
- Lead design changes, obsolescence, supplier changes, and risk mitigation activities.
- Apply design controls, usability, and risk management to released products.
- Support regulatory submissions, technical files, and risk analyses.
- Use post-market feedback to drive product improvements.
- Balance customer needs with safety, regulatory, and business goals.
Skills
Education
Tools
Job description
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
The Staff R&D Engineer is a technical leader within the Sustaining Engineering organization, responsible for supporting the global lifecycle management of commercially released medical devices. This role evaluates existing product designs against evolving clinical needs, customer requirements, regulatory expectations, and business objectives, and develops practical, risk-based solutions that ensure product compliance, continuity of supply, global registration expansion, and long-term portfolio success.
The position collaborates closely with cross-functional teams across R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements, product enhancements, and technical assessments throughout the product lifecycle.
- Lead or serve as the technical lead for sustaining engineering projects supporting global product portfolios.
- Evaluate product designs against evolving clinical, customer, regulatory, and business requirements and identify opportunities for improvement.
- Develop and implement technical solutions that support global product registrations, market expansion, compliance initiatives, and product enhancements.
- Lead technical assessments related to design changes, component obsolescence, supplier changes, manufacturing improvements, and risk mitigation activities.
- Apply design control, human factors, usability, and risk management principles to changes affecting released products.
- Support regulatory submissions, technical files, risk analyses, and design change documentation.
- Leverage post-market surveillance, customer feedback, and clinical insights to drive continuous product improvement.
- Facilitate technical decision-making by balancing customer needs, patient safety, regulatory requirements, business objectives, and implementation feasibility.
- Serve as a technical mentor and subject matter expert within the organization.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related technical discipline with 8+ years of relevant experience; or Medical device industry experience required.
- Demonstrated experience supporting commercially released medical devices through lifecycle management, design changes, or sustaining engineering initiatives.
- Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971).
- Working knowledge of biocompatibility principles (ISO 10993), clinical use considerations, and regulatory requirements impacting product design and market access.
- Experience supporting global regulatory submissions, product registrations, and technical documentation.
- Ability to perform complex technical evaluations and develop practical, compliant engineering solutions.
- Understanding of the interactions between product design, materials, manufacturing processes, patient safety, regulatory requirements, and clinical performance.
- Strong analytical and systems-thinking capabilities.
- Excellent communication skills with the ability to translate complex technical information across organizational levels.
- Ability to evaluate technical, regulatory, clinical, and business tradeoffs to make sound recommendations.
- Proven ability to influence cross-functional teams and drive alignment without direct authority.
- Master's degree in a related engineering discipline with 6+ years of relevant experience.
- Advanced degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related discipline.
- Experience supporting global registration expansion and international regulatory requirements.
- Experience with design verification and validation, root cause investigations, post-market surveillance, and complaint analysis.
- Knowledge of plastics engineering, fluid mechanics, infusion systems, medical device materials, or high-volume manufacturing.
- Experience with statistical analysis and data analytics tools such as Minitab.
- Demonstrated ability to lead complex cross-functional initiatives and influence technical strategy across multiple products or platforms.
This role operates with a high degree of technical independence and is expected to influence product strategy, technical decision-making, and lifecycle management activities across multiple products and geographies. The Staff Engineer identifies opportunities to enhance product performance, support global market access, mitigate risk, and ensure the continued success of the product portfolio through practical, patient-focused, and compliant engineering solutions.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
The expected Base Pay Range for this role is $135,500.00 - $216,800 Annual USD plus incentives. Final compensation will be determined based on experience, skills, and geographic location.
At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
Candidates whose job duties will be physically performed within unincorporated Los Angeles County limits: All qualified Applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. BD abides by any and all laws or regulations that impose restrictions or prohibitions for hiring applicants with criminal histories for posted positions.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
USA NJ - Franklin Lakes
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You.".
$135,500.00 - $216,800.00 USD Annual
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