Failure Analysis Engineer (Medical Devices)

Location: Onsite in Acton, Massachusetts, United States; office, plant, and lab work required

Annual base salary: $77,300–$116,000 for U.S.-based positions; incentive compensation may also apply.

Company

hirify.global develops medical device products for diabetes management and other therapeutic applications, including the Omnipod insulin delivery platform.

What you will do

• Conduct failure analysis investigations involving returned medical devices, manufacturing nonconformances, complaints, and other quality issues.
• Perform root cause analysis on complex failures and recurring trends in collaboration with Quality, Post-Market, Manufacturing, Supplier Quality, and Engineering teams.
• Analyze device history records, manufacturing data, test results, inspection records, and complaint information to identify failure contributors.
• Prepare technical reports and maintain Quality System records, including training records, NCMRs, CAPAs, and Quality Events.
• Evaluate manufacturing and engineering controls to improve product safety, process efficiency, and reliability.
• Support internal and external audits, regulatory inspections, and the implementation of inspection and testing procedures.

Requirements

• Bachelor’s degree in engineering, such as Mechanical, Biomedical, Electrical, Manufacturing, or Materials Science, or equivalent education and experience.
• 3–5 years of experience in engineering, quality, reliability, or failure analysis, preferably in the medical device industry.
• Experience conducting root cause investigations and technical problem-solving activities.
• Knowledge of CAPA, NCMR, risk management, medical device manufacturing, and quality systems.
• Familiarity with QSR Part 820, ISO 13485, and ISO 14971.
• Strong analytical, troubleshooting, technical writing, communication, organizational, and data interpretation skills; proficiency with Excel, Minitab, or comparable statistical software.

Nice to have

• Electrical and mechanical engineering background.
• Experience with medical device assembly, sterilization, packaging, and testing processes.

Culture & Benefits

• Full-time employee position within the Quality department.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Performance-driven environment focused on customer expectations and shared values.

Hiring process

• Applications are submitted online through the hirify.global Careers site.
• The posting remains open until the position is filled.