Manager, Product Engineering (Medical Devices)

TL;DR

Manager, Product Engineering (Medical Devices): Delivers engineering solutions to sustain production of implantable medical devices with an accent on managing design changes, supplier interactions, CAPAs, NCRs, and compliance projects. Focus on leading cross-functional teams in design reviews, verification/validation protocols, and regulatory adherence to improve performance, reduce costs, and enhance manufacturability.

Merrimack, NH, US. Hybrid: 1-2 days remote per week (site-based).

$120-145k, 15% 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, employing over 12,000 people worldwide.

What you will do

• Lead design change projects to improve product performance, reduce costs, and enhance manufacturability of implantable medical devices.
• Investigate and address CAPAs, NCRs, and product complaints related to design issues.
• Collaborate with suppliers on component changes and lead supplier selection/evaluation.
• Conduct design reviews, create/execute verification, validation, and process protocols.
• Manage cross-functional project teams, mitigate risks, and track deliverables.
• Mentor staff, provide technical expertise in audits, and update senior leadership.

Requirements

• Bachelor’s degree in Engineering or scientific discipline (chemical, biomedical, materials, or mechanical).
• Minimum 7 years in medical device industry with design controls, production, process controls, or R&D experience.
• Minimum 3 years managing others and leading cross-functional project teams.
• Knowledge of 21 CFR Part 820 and medical device standards.
• Strong analytical, problem-solving, communication, and collaboration skills.
• Proficiency in Microsoft Office; knowledge of Good Documentation Practices (GDP).

Nice to have

• Experience with Agile PLM and Minitab.

Culture & Benefits

• Comprehensive health, dental, vision insurance, life insurance, short/long-term disability.
• 401k with company match, paid time off, commuter benefits, flexible spending accounts.
• Wellness initiatives, health assistance resources, parental/caregiver leave, tuition reimbursement.
• Some travel to sites (<5%), extended hours during peak cycles possible.