Sr. Engineer, Product (Medical Devices)

Location: Merrimack, New Hampshire, United States; site-based hybrid schedule with 1–2 days at home

Salary: $95,000–$120,000 annually, plus 10% STIP

Company

hirify.global provides medical technology and solutions for hospitals and life science institutions, including intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science.

What you will do

• Lead design change projects for commercially released implantable and consumable medical devices, improving performance, cost, and manufacturability.
• Lead CAPA, NCR, product complaint, OOS, and OOT investigations related to product, process, testing, and equipment issues.
• Coordinate cross-functional design reviews, process improvement initiatives, supplier evaluations, and quality/compliance projects.
• Create and execute design verification and validation, process validation, test method validation, equipment qualification, engineering, and feasibility studies.
• Maintain design input/output documentation, Design History Files, and Device Master Records throughout the product lifecycle.
• Lead project teams, track risks and deliverables, support audits, provide management updates, and mentor junior staff.

Requirements

• Bachelor’s degree in engineering or a related scientific discipline such as chemical, biomedical, materials, or mechanical engineering.
• At least five years of experience in the medical device industry or another regulated industry, including design controls and production or process controls.
• Experience leading cross-functional project teams and making technical decisions.
• Knowledge of 21 CFR Part 820, medical-device standards, and Good Documentation Practices.
• Strong analytical, problem-solving, communication, collaboration, and Microsoft Office skills.
• Ability to work at the Merrimack, NH site; the role may require 5–10% travel and extended hours during peak business cycles.

Nice to have

• Experience with Agile PLM and Minitab.

Culture & Benefits

• Health, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off, parental and caregiver leave.
• Wellness initiatives, health assistance resources, life insurance, and disability benefits.
• Flexible spending accounts, commuter benefits, and tuition reimbursement.