Sr Product Engineer (Medical Devices)

Location: Onsite in North Haven, Connecticut, United States. Candidates must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is not available for this role.

Salary: $104,000–$156,000 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, including surgical stapling devices, to improve patient outcomes.

What you will do

• Lead released product engineering activities for surgical stapling devices, including product design, corrective and preventive actions, sustainability, and clinical performance enhancements.
• Lead or champion initiatives from concept through implementation and present initiative status to management, peers, executives, and customers.
• Analyze complex technical issues, identify root causes of customer complaints, and determine corrective actions.
• Collaborate on verification testing, product specifications, reliability, manufacturability, and customer requirements.
• Apply regulatory standards, design controls, risk analysis, and established SOPs to sustaining engineering projects.
• Provide technical leadership and mentorship to junior engineers and may lead subprojects.

Requirements

• Bachelor’s degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
• For degrees earned outside the United States, a degree meeting 8 C.F.R. § 214.2(h)(4)(iii)(A) requirements is required.
• Ability to develop practical solutions to difficult and highly complex technical problems requiring research and analysis.
• Ability to collaborate on testing, evaluate protocols and results, and interpret functional and customer requirements.
• Ability to conduct project management documentation, design controls, risk analysis, and prepare analytical reports, presentations, and spreadsheets.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment.

Nice to have

• Mechanical design experience and experience designing or redesigning medium- to high-complexity medical devices and subsystems.
• Experience with design change control, Design for Manufacturability, Design for Assembly, FMEA, prototypes, experiments, numerical verification, finite element analysis, and tolerance analysis.
• DRM, DFSS, and/or Six Sigma training or experience.
• Experience preparing documentation under internal SOPs and Design Control.
• Experience interacting with suppliers and participating in pre-clinical in vivo labs, hospital observations, and customer interactions.
• Strong communication, teamwork, technical information interpretation, and Microsoft Office skills.

Culture & Benefits

• Onsite work environment focused on healthcare technology, patient outcomes, innovation, and technical collaboration.
• Health, dental, and vision insurance; health savings and flexible spending accounts; life insurance; and long-term disability coverage for eligible regular employees.
• Paid time off, paid holidays, short-term disability, 401(k) with employer contribution and match, employee stock purchase plan, and employee assistance program.
• Tuition assistance or reimbursement, dependent daycare spending account, and a global well-being program.
• Regular employees may participate in incentive plans and applicable retirement and capital accumulation programs.