Product Engineer II (Medical Devices)

Location: North Haven, Connecticut, United States; hybrid work model with on-site presence four days per week. Minimal travel may include manufacturing sites or supplier visits.

Salary: $80,000–$120,000 USD per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Support sustaining engineering for released open, laparoscopic stapling devices and GYN products.
• Evaluate and implement product and process changes while preparing design and test documentation.
• Develop and review verification testing, protocols, results, specifications, and reliability requirements.
• Investigate customer complaints and product, supplier, and manufacturing issues, determining root causes and corrective actions.
• Apply medical device regulations, design controls, risk analysis, and established SOPs to engineering projects.
• Provide technical contributions, lead subprojects, and prepare analytical reports, presentations, and spreadsheets.

Requirements

• Bachelor’s degree required, or an advanced degree with no prior experience.
• At least two years of relevant experience, unless qualifying through an advanced degree.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not available for this role.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Ability to work on-site four days per week in North Haven, Connecticut, with occasional travel of up to 10% potentially required.

Nice to have

• Engineering degree and experience with FDA 21 CFR Part 820, ISO 13485, ISO 14971, or GMP.
• Knowledge of statistical analysis, Minitab, DOE, process capability, measurement systems, and confidence interval analysis.
• Experience with process validation, IQ, OQ, PQ, TMV, DFMEA, PFMEA, DFA/DFM, and GD&T.
• Experience with PTC Creo or SolidWorks, CAPA, DMAIC, A3, 5 Whys, Ishikawa diagrams, and Pareto charts.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Flexible Spending Account, life insurance, and long-term disability coverage.
• Paid time off, paid holidays, short-term disability, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.