Senior R&D Engineer, Medical Devices & Lifecycle

BD; Juneau (AK); Hybrid; USD 136,000 - 217,000; Full time

Benefits offered by this job

Medical coverage

Health Savings Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Short‑term disability

Job summary

BD is seeking a Staff R&D Engineer to lead sustaining engineering across global medical device portfolios. You will evaluate designs, address regulatory needs, and implement compliant improvements throughout product lifecycles.

You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design changes, risk management, and product registrations while mentoring teams and ensuring continuity of supply.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related technical discipline with 8+ years of relevant experience.
• Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971).
• Experience supporting global regulatory submissions, product registrations, and technical documentation.

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

Cross-functional collaboration

Regulatory knowledge

Communication skills

Risk assessment

Education

Bachelor's degree in Mechanical/ Biomedical/ Systems Engineering

Job description

BD is seeking a Staff R&D Engineer to lead sustaining engineering across global medical device portfolios. You will evaluate designs, address regulatory needs, and implement compliant improvements throughout product lifecycles.

You will collaborate with R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design changes, risk management, and product registrations while mentoring teams and ensuring continuity of supply.