Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Developing and maintaining risk management strategies for new product development in the surgical operating unit with an accent on patient safety and regulatory compliance. Focus on leading DFMEAs, hazard analysis, and ensuring traceability between requirements and design outputs.

Location: Onsite in North Haven, Connecticut, USA. Must possess unrestricted U.S. work authorization.

Salary: $66,400.00 - $99,600.00

Company

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

What you will do

• Develop and maintain comprehensive risk management strategies, including risk management files, plans, and reports.
• Lead hazard and risk analysis and Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams.
• Analyze product complaints and integrate security measures to protect against potential vulnerabilities.
• Ensure compliance with FDA, ISO (14971, 13485, 62304), and other international regulatory standards.
• Oversee design validation and verification activities, including the creation of test plans, protocols, and reports.
• Develop post-market surveillance plans and conduct root cause analysis for field issues during initial launch.

Requirements

• Bachelor’s degree in a relevant field.
• Unrestricted U.S. work authorization at the time of hire (Sponsorship is not offered for this level).
• Ability to be independently mobile and interact with computer systems in an office environment.
• Strong team player mindset with a self-starter and inquisitive approach.

Nice to have

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt, or AAMI design control certification.
• Experience within the medical device industry or other regulated engineering fields.
• Proficiency in quality management systems, risk management, and statistics.
• Basic knowledge of human anatomy, physiology, and surgical procedures.

Culture & Benefits

• Competitive salary and eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive Health, Dental, and Vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and tuition assistance/reimbursement.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).