Risk Management Quality Engineer I (Medical Devices)

TL;DR

Risk Management Quality Engineer I (Medical Devices): Developing and maintaining risk management activities for surgical medical devices throughout the new product development lifecycle with an accent on hazard analysis, design controls, and regulatory compliance. Focus on leading DFMEAs, integrating cybersecurity and process risks, establishing traceability, and evaluating field issues and design changes to protect patient safety.

Location: North Haven, Connecticut, United States; hybrid arrangement with a minimum of four days per week onsite. Candidates below the Principal level must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is not available.

Salary: $66,400–$99,600 USD base salary, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices that aim to alleviate pain, restore health, and extend life.

What you will do

• Develop risk management strategies, plans, reports, and files across the medical device product lifecycle.
• Lead hazard analyses, risk reviews, DFMEAs, and integration of Process FMEA and User FMEA outputs.
• Define and implement risk controls, maintain traceability between requirements and design outputs, and assess the safety impact of design changes.
• Analyze complaints and initial-launch field issues, including root-cause analysis, risk evaluation, and containment strategies.
• Develop post-market surveillance plans and support design reviews, verification, validation, audits, and inspections.
• Collaborate with engineering, R&D, clinical, and other cross-functional teams to ensure patient safety, product quality, and compliance.

Requirements

• Bachelor's degree in engineering or a related technical field.
• Strong interest in risk management, product development, design controls, and regulatory compliance in medical devices.
• Knowledge of applicable requirements and standards, including FDA regulations, ISO 14971, ISO 13485, IEC 62304, and FDA Part 820.
• Strong written, verbal, digital communication, teamwork, self-direction, curiosity, and learning ability.
• Unrestricted U.S. work authorization is required; H-1B, TN, J, and other sponsorship is unavailable for this role.

Nice to have

• Experience with medical devices, pharmaceuticals, combination products, or new product development.
• Background in quality engineering, risk management, R&D, systems engineering, or clinical risk assessment.
• Experience with Minitab or other statistical analysis software.
• Design for Six Sigma, Design for Reliability, CQE, Six Sigma Green Belt, or AAMI design control certification.
• Proficiency with Microsoft Office tools.

Culture & Benefits

• In-person collaboration and cross-functional work in a patient-focused medical technology organization.
• Health, dental, and vision insurance, plus HSA and healthcare FSA options.
• 401(k) plan with employer contribution and match, incentive plans, paid time off, and paid holidays.
• Life insurance, disability coverage, employee assistance, tuition assistance, and dependent daycare spending account.
• Employee Stock Purchase Plan and global well-being program.