Sr. Manager, Sustaining & LifeCycle Engineering (Medical Devices)

Location: Hybrid role based in Wayne, New Jersey, United States

Salary: $190,000–$215,000 per year; target bonus: 25%

Company

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

What you will do

• Lead multidisciplinary sustaining engineering and product lifecycle management teams for commercially released medical devices.
• Direct design changes, product enhancements, engineering change orders, component obsolescence programs, cost reduction initiatives, and manufacturing support.
• Investigate and resolve product complaints, nonconformances, CAPAs, field issues, and root causes.
• Oversee system-level impact assessments, verification and validation activities, and product maintenance projects.
• Partner with Supply Chain, Operations, Quality, Regulatory Affairs, Manufacturing, Service, and Supplier Quality organizations.
• Manage budgets, resource planning, project priorities, team development, and lifecycle strategies including technology refresh and end-of-life planning.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, or Biomedical Engineering; a master’s degree in engineering, life sciences, business, or a related field is preferred.
• 10+ years of engineering experience in the medical device industry, including at least 5 years of leadership or management experience.
• Experience with sustaining engineering, product lifecycle management, post-market engineering, design changes, CAPAs, complaint investigations, risk management, and regulatory compliance.
• Experience working with FDA, ISO 13485, CE Mark, and global regulatory frameworks.
• Knowledge of design controls, change management, post-market surveillance, product reliability, supplier management, and cost reduction.
• Strong people leadership, project management, analytical, communication, negotiation, and cross-functional collaboration skills.

Nice to have

• Experience with cardiovascular, critical care, acute care, or other complex medical device technologies.
• Master’s degree in engineering, life sciences, business, or a related field.

Culture & Benefits

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