Senior Product Engineer (Medical Devices)

TL;DR

Senior Product Engineer (Medical Devices): Delivering engineering solutions to sustain production of implantable and consumable medical devices with an accent on design changes, compliance projects, and supplier management. Focus on leading CAPAs, NCRs, product complaints investigations, executing design verification and validation protocols, and maintaining design history files.

Location: Merrimack, NH, US (Hybrid: 1-2 days remote, site-based, onsite role)

Salary: $95-120k + 10% STI

Company

hirify.global provides hospitals and life science institutions with products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science, sold in more than 135 countries.

What you will do

• Lead design change projects to improve product performance, reduce costs, and enhance manufacturability.
• Investigate and address CAPAs, NCRs, and product complaints related to design issues.
• Conduct design reviews to evaluate requirements, identify problems, and ensure design capability.
• Create and execute protocols for design verification, validation, engineering studies, process validation, and equipment qualification.
• Process change orders, perform product testing, OOS/OOT investigations, and maintain DHF/DMR.
• Lead cross-functional project teams, mentor juniors, provide technical expertise for suppliers, and support audits.

Requirements

• Bachelor’s degree in Engineering or scientific discipline (chemical, biomedical, materials, or mechanical).
• Minimum 5 years in medical device industry with experience in design controls, production/process controls, or R&D.
• Experience leading cross-functional project teams as a decision-maker.
• Knowledge of 21 CFR Part 820 and relevant medical device standards.
• Strong Microsoft Office skills (Word, Excel, PowerPoint).
• Strong analytical, problem-solving, communication, and collaboration skills; self-motivated.

Nice to have

• Experience with Agile PLM and Minitab.
• Knowledge of Good Documentation Practices (GDP).

Culture & Benefits

• Comprehensive health, dental, vision insurance, 401k with company match, life insurance, short/long-term disability.
• Paid Time Off, parental/caregiver leave, tuition reimbursement, commuter benefits, health/dependent care FSAs.
• Wellness initiatives and health assistance resources; may require 5-10% travel and extended hours during peaks.