Quality Engineer - NPI Programs (Medical Devices)

Location: Acton, Massachusetts, United States; onsite role

Annual base salary: $70,400–$105,650 for U.S.-based positions. Incentive compensation may also apply.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery solutions.

What you will do

• Lead quality engineering activities for prototype, pilot, clinical, and development manufacturing builds.
• Develop inspection plans, control plans, procedures, work instructions, test methods, and quality standards.
• Support design controls, traceability, Design History File and Device History Record compliance, lot release, and clinical build readiness.
• Analyze quality and manufacturing data, investigate nonconformances, perform root cause analysis, and implement CAPA.
• Facilitate DFMEA, PFMEA, process control, equipment and process validation activities, including IQ/OQ/PQ.
• Partner with R&D, Manufacturing Engineering, Operations, Clinical, and Regulatory Affairs on manufacturability, design transfer, commercialization, and production readiness.

Requirements

• Bachelor's degree in engineering or a related technical discipline.
• At least 3 years of Quality Engineering experience in a regulated industry.
• Experience with inspection methods, metrology systems, test methods, measurement system analysis, statistical analysis, and process capability studies.
• Knowledge of FDA Quality System Regulations, including 21 CFR 820, ISO 13485, GMP, design controls, risk management, and medical device quality systems.
• Experience with DHF, DHR, manufacturing operations, process development, pilot manufacturing, or NPI programs.
• Experience with equipment and process validation activities and strong analytical, problem-solving, communication, and cross-functional collaboration skills.

Nice to have

• Medical device industry experience.
• Experience supporting new product development programs.
• Experience driving design control, risk management, and manufacturing quality improvements.

Culture & Benefits

• Full-time employment in a fast-paced product development environment.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and employee wellness programs.