Regeneron is currently looking for a Sustaining Engineer for our Process Sciences Drug Product Engineering team. The Sustaining Engineer monitors, maintains, and/or improves the quality and performance of commercial combination products through performing technical evaluations, maintaining design history files, and implementing design improvements to address user and/or business needs.
As a Sustaining Engineer, a typical day might include the following:
- Performing design change assessments to determine impact of changes to commercial products.
- Implement design changes to improve the quality of existing products and/or the customer experience.
- Support new indications, regulations, and marketed regions associated with existing commercial products.
- Maintain Risk Management Files for existing products based on post market surveillance.
- Facilitate design transfer of existing products to new manufacturing sites.
- Perform technical evaluations related to supplier and manufacturing changes to existing products.
- Developing and maintaining effective interactions with key technical counterparts within the Regeneron organization, including quality assurance, external manufacturing, and various engineering functions, including relevant non-IOPS functions.
- Assuring work activities are conducted in a manner aligned with all applicable regulations and industry standards.
This role might be for you if:
- You are familiar with development or maintenance of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971.
- Have strong technical writing and oral communication skills.
- Can manage multiple projects and timelines.
- Have working knowledge of medical device regulatory requirements.
- Enjoy writing technical documents such as impact assessments, technical memos, and other engineering documentation.
- Can build strong working relationships cross-functionally.
To be considered for the Sustaining Engineer you must have a BS in Engineering, Mechanical Engineering, Biomedical Engineering and Bioengineering is preferred. For various levels you must have the following:
- Associate Sustaining Engineer: 0-2 years of relevant experience
- Sustaining Engineer: 2+ years of relevant experience
- Sr Sustaining Engineer: 5+ years of relevant experience
Previous project management/sustaining engineering experience preferred. Experience in the medical device and/or combination product industry is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)