Sr Quality Engineer (Medical Devices)

Location: Lafayette, Colorado, United States; minimum 4 days per week onsite

Salary: $98,400–$147,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies, services, and solutions for healthcare markets worldwide.

What you will do

• Develop and maintain risk management strategies, plans, reports, and files throughout the medical device product lifecycle.
• Lead hazard analyses, risk reviews, DFMEAs, and the integration of Process FMEA and User FMEA activities.
• Collaborate with surgical operating unit and new product development teams to embed patient safety and product quality into designs.
• Evaluate product complaints, field issues, design changes, root causes, risk controls, and product containment strategies.
• Maintain traceability between risk files, requirements, and design outputs using a requirements management tool.
• Support design verification, validation, regulatory audits, inspections, and post-market surveillance activities.

Requirements

• Bachelor’s degree in engineering or a related technical field.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and relevant medical device standards.
• Strong analytical, problem-solving, root cause analysis, communication, leadership, and project management skills.
• Experience in a regulated engineering field; medical device industry experience is preferred.
• Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

• Certified Quality Engineer, Six Sigma Green Belt, or equivalent certification.
• AAMI design control certification.
• Advanced degree.
• Basic knowledge of human anatomy, physiology, and surgical procedures.

Culture & Benefits

• In-person collaboration and cross-functional exchanges are emphasized.
• Health, dental, vision, life, and disability insurance options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, employee stock purchase plan, and employee assistance program.
• Tuition assistance, healthcare spending accounts, and other well-being and incentive programs.