Risk Management Quality Engineer (Medtech)

TL;DR

Risk Management Quality Engineer (Medtech): Developing and maintaining comprehensive risk management strategies for new surgical medical devices with an accent on design controls, regulatory compliance, and patient safety. Focus on leading FMEA activities, analyzing product performance, and ensuring traceability throughout the product lifecycle.

Location: Must be based in North Haven, Connecticut, USA. Role requires minimum 4 days a week onsite.

Salary: $79,200–$118,800 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Develop and maintain risk management plans, reports, and files for new product development.
• Lead hazard analysis and Design Failure Modes and Effects Analyses (DFMEA) with cross-functional teams.
• Ensure traceability between risk management files, requirements, and design outputs.
• Analyze product complaints and lead field issue evaluations to identify root causes.
• Integrate product security measures into risk management documentation.
• Oversee design verification and validation activities to ensure compliance with safety standards.

Requirements

• Must possess unrestricted U.S. work authorization (sponsorship not available for this level).
• Bachelor’s degree in engineering or related technical field with 2+ years of experience, or advanced degree with 0-2 years of experience.
• Strong background in risk management, design controls, and regulatory compliance within the medical device industry.
• Proficiency in medical device standards such as ISO 14971, ISO 13485, and FDA Part 820.
• Ability to work onsite in North Haven, CT at least 4 days per week.

Nice to have

• Experience with Minitab or statistical analysis software.
• Certifications such as Certified Quality Engineer (CQE) or Six Sigma Green Belt.
• Clinical knowledge supporting risk assessment.
• Experience with Design for Six Sigma or Design for Reliability methodologies.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and short-term incentive plans.
• Commitment to professional growth and cross-functional collaboration.