Staff R&D Engineer - MedTech Sustaining & Compliance

BD; Arkansas; Sur place; USD 136 000 - 217 000; Plein temps

Avantages offerts par ce poste

BD benefits package

401(k) plan

Résumé du poste

BD is seeking a Staff R&D Engineer to lead sustaining engineering for global medical device portfolios. You will collaborate across R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements and lifecycle support.

The role requires a strong background in design controls, risk management, and regulatory documentation, with a focus on global registrations and market expansion. On-site work is standard in this role.

Qualifications

• Bachelor's degree in mechanical/biomedical/sys engineering or related technical discipline with 8+ years of relevant experience.

Responsabilités

• 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.

Connaissances

Sustaining engineering

Design controls

Risk management

Regulatory submissions

Cross-functional collaboration

Technical mentoring

Formation

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related technical discipline

Description du poste

BD is seeking a Staff R&D Engineer to lead sustaining engineering for global medical device portfolios. You will collaborate across R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements and lifecycle support.

The role requires a strong background in design controls, risk management, and regulatory documentation, with a focus on global registrations and market expansion. On-site work is standard in this role.