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 and 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
• 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
• Strong analytical problem-solving skills and ability to deliver clear technical writing and crisp oral communication
• Hand-on expertise in Design History File management and sustaining engineering for medical devices and/or combination products

Skills

• Excellent project management and leadership skills
• Ability to work effectively in a fast-paced, dynamic environment
• Strong interpersonal and communication skills
• Experience with regulatory compliance and risk management

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