Manager, Sustaining Engineering

Regeneron Pharmaceuticals•Valley, AL

2d•$108,000 - $176,000•Onsite

About The Position

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.

Requirements

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
B.S in Engineering; Biomedical Engineering, Mechanical Engineering, Industrial Engineering is preferred.
7+ years of relevant experience
Previous supervisory/ people leadership experience is required.

Nice To Haves

Previous experience in manufacturing of medical devices and/or combination products is preferred.

Responsibilities

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