Senior Staff Engineer, Medical Device Sustaining

BD; California; On-site; USD 136,000 - 217,000; Full time

Job summary

BD in USA NJ - Franklin Lakes is seeking a Staff R&D Engineer in Sustaining Engineering to lead lifecycle management of medical devices, assess designs against clinical needs, regulatory expectations, and business goals, and deliver compliant, continuous product improvements.

You'll collaborate with R&D, Quality, Regulatory, Operations, Manufacturing, and Marketing to drive design changes, risk assessments, and technical files, mentoring others while balancing patient safety and market access.

Qualifications

• Bachelor's degree in mechanical/biomedical/systems engineering or related field with 8+ years of relevant experience; or medical device industry experience required.
• Solid familiarity with design controls (21 CFR 820, ISO 13485) and risk management (ISO 14971).
• Experience supporting lifecycle management of medical devices and sustaining engineering initiatives.

Responsibilities

• Lead or serve as the technical lead for sustaining engineering projects across global product portfolios.
• Evaluate product designs against evolving clinical, customer, regulatory, and business requirements and identify improvement opportunities.
• Develop and implement technical solutions supporting global registrations, market expansion, and compliance initiatives.
• Lead assessments related to design changes, obsolescence, supplier changes, and manufacturing improvements.
• Apply design controls, human factors, usability, and risk management to changes affecting released products.
• Support regulatory submissions, technical files, risk analyses, and design change documentation.
• Leverage post-market surveillance and customer feedback to drive continuous improvement.
• Facilitate technical decision-making balancing customer needs, safety, regulatory requirements, and feasibility.
• Serve as a technical mentor and SME within the organization.

Skills

Analytical thinking

Cross-functional influence

Regulatory understanding

Communication skills

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related technical discipline with 8+ years experience

Job description

BD in USA NJ - Franklin Lakes is seeking a Staff R&D Engineer in Sustaining Engineering to lead lifecycle management of medical devices, assess designs against clinical needs, regulatory expectations, and business goals, and deliver compliant, continuous product improvements.

You'll collaborate with R&D, Quality, Regulatory, Operations, Manufacturing, and Marketing to drive design changes, risk assessments, and technical files, mentoring others while balancing patient safety and market access.