Sr. Reliability Engineer (Stapling Portfolio / Surgical)

Location: North Haven, Connecticut, United States; minimum four days per week onsite for laboratory testing, product investigations, and cross-functional collaboration. Candidates below the Principal level must possess unrestricted U.S. work authorization at hire and throughout employment. U.S. work authorization sponsorship is offered only for Principal-level roles and above.

Salary: $107,200–$160,800 USD annually for U.S. locations excluding Puerto Rico and specific California locations. The position is eligible for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, with products used by patients worldwide.

What you will do

• Lead reliability engineering programs, including reliability demonstration testing, accelerated life testing, reliability growth initiatives, predictive modeling, and test planning.
• Investigate product performance, field quality, and manufacturing issues; identify failure mechanisms and root causes; and drive corrective actions.
• Apply DOE, regression analysis, confidence intervals, hypothesis testing, trend analysis, and other statistical methods to support engineering decisions.
• Partner with Research & Development, Manufacturing, Supplier Quality, and Complaint Handling teams to evaluate design changes and improve product robustness.
• Conduct hands-on product evaluations, laboratory investigations, technical assessments, verification, validation, and design review support.
• Lead risk management activities, including hazard analysis, FMEA, risk assessments, and maintenance of risk management documentation.

Requirements

• Bachelor’s degree with 4+ years of relevant experience, or Master’s degree with 2+ years of relevant experience, or PhD.
• Experience in medical device, pharmaceutical, biotechnology, or another regulated product industry.
• Unrestricted U.S. work authorization at the time of hire and for the duration of employment.
• Ability to support quality, reliability, and regulatory requirements when reviewing engineering, supplier, and manufacturing changes.
• Ability to analyze complaint, post-market, and quality system data to identify trends and drive product and process improvements.

Nice to have

• Experience with design controls, risk management, verification, validation, and engineering change processes.
• Experience supporting embedded software, electronic hardware, circuit board-based, or electromechanical products.
• Experience conducting root cause investigations and resolving product or process quality issues.
• Experience applying statistical methods to product, reliability, quality, or process improvement activities.
• Knowledge of ISO 13485, ISO 14971, IEC 60601, and EU MDR.
• Experience with accelerated life testing, reliability demonstration testing, predictive modeling, and reliability growth analysis.
• Experience using Minitab for DOE, regression analysis, confidence intervals, hypothesis testing, and statistical modeling.
• Experience with Fault Tree Analysis, Fishbone Analysis, 5 Why investigations, and failure mechanism analysis.
• Experience using artificial intelligence tools for engineering analysis, data evaluation, or technical problem solving.
• For bachelor’s degrees earned outside the United States, a degree meeting 8 C.F.R. § 214.2(h)(4)(iii)(A) requirements is required.

Culture & Benefits

• Work in a healthcare technology environment focused on patient outcomes and cross-functional collaboration.
• Regular employees may receive health, dental, and vision insurance; HSA; healthcare FSA; life insurance; disability benefits; and dependent daycare spending accounts.
• Benefits include tuition assistance or reimbursement, paid time off, paid holidays, and paid sick time where applicable.
• Regular employees may receive incentive plans, a 401(k) plan with employer contribution and match, an Employee Stock Purchase Plan, and an Employee Assistance Program.
• Additional retirement and capital accumulation plans are available subject to eligibility requirements.