R&D Product Engineer II (Medical Devices)

Location: North Haven, Connecticut, United States. This is an onsite office role. Candidates must have unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is not available for roles below Principal level.

Salary: $80,000–$120,000 per year, with eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Design, develop, analyze, troubleshoot, and technically support commercialized wound management products and manufacturing activities.
• Own mechanical and packaging design changes for absorbable medical devices inside the sterile barrier.
• Update engineering drawings and specifications using CAD, and perform tolerance stacks and design-change evaluations.
• Plan and execute design studies, verification and validation activities, root-cause investigations, and corrective actions.
• Improve product performance, quality, cost, manufacturability, and supply continuity while maintaining design intent.
• Coordinate testing and technical activities with Design Quality, Manufacturing Engineering, Operations, Supply Chain, suppliers, consultants, and external partners.

Requirements

• Bachelor’s degree in Biomedical, Mechanical, Materials, Manufacturing, or a related engineering discipline, plus 2 years of relevant experience; or a Master’s degree in Engineering with 0–2 years of experience.
• Experience with medical device mechanical design, packaging design, CAD, tolerance stacks, and analytical modeling.
• Experience with injection-molded components, tooling, design verification, design validation, root-cause analysis, and supplier collaboration.
• Familiarity with ISO 13485, FDA Quality System Regulations, and design control or change management processes.
• Strong communication skills and the ability to collaborate across technical and non-technical functions.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience with wound management and absorbable medical products.
• Experience analyzing customer complaints, product returns, or field issues.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, disability coverage, life insurance, and employee assistance resources.
• Health Savings Account, Flexible Spending Account, dependent daycare account, and tuition assistance.
• Employee Stock Purchase Plan and incentive plans.