Senior Product Development Engineer, Medical Devices

Job overview

The Senior Product Development Engineer, Medical Devices role is hybrid in Durham, NC, with work in the office four days a week. Compensation is not specified. The role supports Sanner America’s development of medical devices and drug delivery systems, advancing its purpose of protecting health. The engineer leads complex product development from concept through manufacturing transfer, guiding technical risk reduction, verification and validation, and design-history documentation. The role also mentors junior engineers and coordinates with project, quality, customer, and internal teams to deliver compliant, high-quality products.

What you'll do

• Lead technical product development and project oversight
• manage complex deliverables through the development lifecycle from concept through manufacturing transfer
• track technical risk and guide risk retirement
• mentor junior engineers
• create, review, and release QMS documents and develop test methods and protocols
• inform project budgets
• manage smaller technical projects
• lead risk assessments, verification and validation, test method development, prototype testing, and device failure investigations.

What we're looking for

Skills & competencies

senior product development engineer

medical devices

hybrid

durham nc

product development

design verification

design validation

risk management

iso 14971

iso 13485

sanner america

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual bonus plan
• medical, dental, and vision coverage
• company-provided life insurance and disability
• paid parental leave
• 401(k) match
• LinkedIn Learning access.

Why this role

Requires a bachelor’s degree in engineering or equivalent technical degree; 5+ years of medical-device or similar product development experience preferred. The posting cites ISO 14971, ISO 13485, and CFR 21 knowledge, with ISO 10993 experience a plus; U.S. work authorization without sponsorship is required.

About the employer

GILERO is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.