Principal Risk Management Quality Engineer (Medical Devices)

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

Salary: $120,800–$181,200 per year, plus eligibility for the hirify.global Incentive Plan.

Company

Global healthcare technology company developing medical technologies, services, and solutions.

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, Design FMEA, Process FMEA, and User FMEA activities with cross-functional project teams.
• Define risk controls, evaluate the safety impact of design changes, and maintain traceability between requirements, design outputs, and risk documentation.
• Analyze product complaints and field issues, including root cause analysis, risk evaluation, and product containment during initial launch.
• Develop post-market surveillance plans and integrate product security measures into risk management activities.
• Support design reviews, verification and validation, quality system processes, regulatory audits, and inspections.

Requirements

• Bachelor’s degree in engineering or a related technical field; an advanced degree is preferred.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and related medical device standards.
• Experience in a regulated engineering field, preferably within the medical device industry.
• Strong analytical, problem-solving, root cause analysis, written communication, and cross-functional collaboration skills.
• Proven leadership and project management skills, with the ability to lead teams and manage multiple projects.
• U.S. work authorization is required for roles below Principal level; sponsorship is offered for Principal-level roles and above.

Nice to have

• Certified Quality Engineer, Six Sigma Green Belt, or equivalent certification.
• AAMI design control certification.
• Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
• Basic knowledge of human anatomy, physiology, and surgical procedures.

Culture & Benefits

• In-person collaboration and cross-functional professional development are emphasized.
• Health, dental, and vision insurance, plus health and flexible spending accounts.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and employee assistance resources.