New Product Development Senior Supplier Quality Engineer (Medical Devices)

Location: North Haven, Connecticut, United States; minimum four days per week onsite

Salary: $98,400–$147,600 USD per year

Company

hirify.global develops medical technologies, services, and solutions intended to alleviate pain, restore health, and extend life.

What you will do

• Select, qualify, audit, and manage internal and external suppliers and maintain the Approved Supplier List.
• Monitor supplier parts and manufacturing cycles, resolve supplier issues, manage NCMRs, change requests, CAPA, and quality performance reviews.
• Qualify materials through PPAP, including process validation, test method validation, technical writing, and project management.
• Oversee IQ/OQ/PQ process validation, Master Validation Planning, statistical analysis, and process FMEA activities.
• Collaborate on design controls, DFMEA, Design for Manufacturability and Assembly, process controls, and effective design transfer.
• Coordinate supplier process development to support engineering builds and Design Verification and Validation, including occasional domestic and international supplier travel.

Requirements

• Bachelor’s degree in engineering or a related technical field with at least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
• Extensive knowledge of manufacturing processes for plastics, metals, electronics, and/or product-level assembly.
• Strong understanding of GD&T, FMEA, DFX principles, regulated environments, root cause analysis, and statistical methods.
• Proven leadership, project management, written communication, verbal communication, and cross-functional collaboration skills.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this Senior-level role.

Nice to have

• CQE, Six Sigma Green Belt, or equivalent certification; AAMI design control certification.
• Knowledge of FDA regulations, ISO 13485, ISO 14971, quality management systems, risk management, and regulatory compliance.
• Lead auditor experience and familiarity with SAP, TrackWise, Windchill, or Agile.
• Basic knowledge of human anatomy, physiology, and surgical procedures.

Culture & Benefits

• In-person collaboration and professional growth within a cross-functional medical technology environment.
• Health, dental, and vision insurance, plus health and flexible spending accounts.
• Paid time off, paid holidays, disability coverage, life insurance, and employee assistance programs.
• 401(k) plan with employer contribution and match, incentive plans, employee stock purchase plan, and tuition assistance.
• Eligibility for the hirify.global Incentive Plan short-term incentive.

Hiring process

• Submit a resume and cover letter through the hirify.global careers portal.