Staff Engineer, Medical Device Sustaining Lead

Becton Dickinson; North Carolina; On-site; USD 136,000 - 217,000; Full time

Job summary

BD is seeking a Staff R&D Engineer to lead sustaining engineering for global medical devices, evaluating designs against evolving clinical needs, regulatory expectations, and business objectives to deliver practical, risk-based solutions.

You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design changes, registrations, and lifecycle improvements across product portfolios, ensuring patient safety and regulatory compliance.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related technical discipline with 8+ years of relevant experience; or Medical device industry experience required.
• Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971).
• Working knowledge of biocompatibility principles (ISO 10993), 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.

Responsibilities

• 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.

Skills

Analytical thinking

Systems thinking

Communication skills

Cross-functional influence

Trade-off analysis

Education

Bachelor's degree in Mechanical/ Biomedical Engineering

Master's degree in related field

Tools

Minitab

Job description

BD is seeking a Staff R&D Engineer to lead sustaining engineering for global medical devices, evaluating designs against evolving clinical needs, regulatory expectations, and business objectives to deliver practical, risk-based solutions.

You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design changes, registrations, and lifecycle improvements across product portfolios, ensuring patient safety and regulatory compliance.