Manager, Sustaining Engineering

Manager, Sustaining Engineering

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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. As a Manager, Sustaining Engineering, you'll steer a high-performing team, own design changes from concept to launch, drive risk management with rigor, and orchestrate cross-functional problem solving that elevates patient experience and product quality. You'll also expand our global reach by filing commercial products in new regions and supporting contract manufacturing operation changes and additions.

When & where:

• East Greenbush, New York, United States
• Monday-Friday, 8am-4:30pm

Discover your role:

• Turn complaints into insightfeed 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 investigationsidentify 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

This role requires:

• 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
• Level will be determined based on experience
• Previous supervisory/ people leadership experience
• Previous experience in manufacturing of medical devices and/or combination products

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on?site. Please speak with your recruiter and hiring manager for more information about on?site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$92,200.00 - $176,000.00

Regeneron