Sr. Manager, R&D; Product Excellence (Medical Devices)

Location: Wayne, NJ, US; hybrid work

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

Company

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

What you will do

• Lead design assurance activities across new product development, sustaining engineering, and product lifecycle management.
• Direct product risk management, verification and validation strategies, design reviews, and traceability activities.
• Oversee product stewardship, post-market surveillance, complaint management, lifecycle updates, and product improvement initiatives.
• Lead document control, labeling compliance, UDI oversight, and controlled quality documentation.
• Manage R&D CAPA processes, root cause investigations, effectiveness monitoring, audits, and regulatory inspections.
• Develop departmental goals, metrics, budgets, resources, and high-performing cross-functional teams.

Requirements

• Bachelor’s degree in engineering, life sciences, technical quality, regulatory affairs, or a related technical discipline; a master’s degree is preferred.
• 10+ years of experience in medical device R&D, design assurance, or regulatory compliance, including at least 5 years of progressive leadership or management experience.
• Experience supporting Class II and/or Class III medical devices, new product development, and post-market quality systems.
• Proven expertise in design controls, risk management, verification and validation, CAPA, complaint handling, and regulatory compliance programs.
• Deep knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP, IEC 60601, and IEC 62304.
• Experience with electronic quality management systems, PLM, and document management systems, plus strong analytical, communication, negotiation, and project management skills.

Culture & Benefits

• Hybrid work arrangement in Wayne, New Jersey.
• Health, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off, parental and caregiver leave, and disability benefits.
• Wellness resources, life insurance, flexible spending accounts, commuter benefits, and tuition reimbursement.