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 guide a talented team while owning design changes, risk management, and multi-functional problem solving that directly impacts patient experience and product quality. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• East Greenbush, Rensselaer
• Monday-Friday, 8am-4:30pm

Discover your role:

• Lead and mentor sustaining engineers supporting multiple commercial combination products
• Implement targeted design changes to elevate quality and customer experience
• Conduct design change assessments and technical evaluations for supplier and manufacturing changes
• Drive and document investigations into customer complaints to identify root cause and corrective actions
• Maintain and evolve Risk Management Files leveraging post‑marketing surveillance and manufacturing signals
• Facilitate design transfer of existing products to new manufacturing sites with rigor and speed
• Integrate field‑proven performance enhancements into ongoing and new product development efforts
• 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
• Deep understanding of FDA regulations relevant to combination products, including 21 CFR Part 3 and design controls per 21 CFR 820.30
• Hands‑on experience with design history file management and sustaining engineering for medical devices and/or combination products
• Strong analytical problem‑solving skills paired with clear technical writing and crisp oral communication
• Proven project leadership: you balance business objectives with technical constraints and keep cross‑functional teams moving
• A continuous improvement mindset and the interpersonal skills to build trust across functions

This role requires:

To be considered for the Manager Sustaining Engineering you must have a B.S in Engineering; Biomedical Engineering, Mechanical Engineering, Industrial Engineering is preferred. For various levels you must have the following:

• Associate Manager Sustaining Engineering: 6+years of relevant experience
• Manager Sustaining Engineering: 7+ years of relevant experience

Previous experience in manufacturing of medical devices and/or combination products is preferred. Previous supervisory/ people leadership experience is required. Level is determined based on qualifications relevant to the role.

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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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)

$108,000.00 - $176,000.00