Manager, Sustaining Engineering

About the role

Join Regeneron’s Combination Products team and lead the engineering charge that keeps our commercial products safe, reliable, and continuously improving in the hands of patients and providers.

Responsibilities

• Turn complaints into insight—feed real-world experience directly into risk management
• Partner with development team to share post market feedback for new product development
• Lead and mentor sustaining engineers across multiple commercial combination products throughout the lifecycle
• Implement targeted design changes to elevate quality and customer experience
• Drive and document customer complaint investigations—identify root causes and implement corrective and preventive actions
• Facilitate design transfer of existing products to new manufacturing sites with rigor and speed
• Participate in cross-functional design teams to resolve issues quickly and prevent recurrence
• Build and grow strong relationships with internal stakeholders and key external partners
• Demonstrate deep understanding of FDA regulations for combination products, including 21 CFR Part 3 and design controls per 21 CFR 820.30
• Apply hands-on expertise in Design History File management and sustaining engineering for medical devices and/or combination products
• Apply strong analytical problem-solving skills and deliver clear technical writing and crisp oral communication
• Lead projects that balance business objectives with technical constraints and keep cross-functional teams moving

Requirements

• B.S in Engineering; Biomedical Engineering, Mechanical Engineering, Industrial Engineering is preferred
• Associate Manager sustaining Engineering: 6+ years of experience
• Manager sustaining Engineering: 7+ years of experience
• Previous supervisory/people leadership experience
• Previous experience in manufacturing of medical devices and/or combination products

Qualifications

• Deep understanding of FDA regulations for combination products, including 21 CFR Part 3 and design controls per 21 CFR 820.30
• Hands-on expertise in Design History File management and sustaining engineering for medical devices and/or combination products
• Strong analytical problem-solving skills
• Clear technical writing and crisp oral communication

Skills

• Strong project management skills
• Excellent communication and collaboration abilities
• Experience with regulatory compliance and risk management
• Ability to manage cross-functional teams

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$92,200.00 - $176,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm