Associate Sustaining Engineer
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sustaining Engineer to join our sustaining engineering group, supporting our commercial combination products in a hybrid role. In this role, you will monitor and improve product quality and performance while collaborating with cross-functional design teams and key business partners.
Job description
Build our future together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sustaining Engineer to join our sustaining engineering group, supporting our commercial combination products in a hybrid role. In this role, you will monitor and improve product quality and performance while collaborating with cross-functional design teams and key business partners.
Discover your role
- Participate in manufacturing investigations and corrective and preventive action (CAPA) resolutions to improve processes
- Perform design change assessments and technical evaluations, including supplier, label, and component changes
- Implement design changes that improve product quality and customer experience
- Maintain design history files and Risk Management Files using post-market surveillance data
- Manage change and regulatory notifications, and implement changes resulting from complaints
- Facilitate design transfer of existing products to new manufacturing sites
- Participate in cross-functional design teams to address issues
- Build strong business partner relationships so sustaining work runs efficiently
This role requires
- Bachelor's degree in Engineering (mechanical or biomedical engineering helpful)
- 0-2+ years in the medical or combination device industry, or equivalent education and experience
- Experience writing technical documents such as impact assessments and technical memos
- Working knowledge of medical device regulatory requirements
- Medical device industry and sustaining engineering experience preferred
- Experience developing regulated devices or combination products under Design Control (21 CFR 820) and ISO 14971 preferred
- Strong technical writing and oral communication skills
- Ability to manage multiple projects and timelines and build cross-functional relationships
Requirements
- Bachelor's degree in Engineering (mechanical or biomedical engineering helpful)
- 0-2+ years in the medical or combination device industry, or equivalent education and experience
- Experience writing technical documents such as impact assessments and technical memos
- Working knowledge of medical device regulatory requirements
- Strong technical writing and oral communication skills
- Ability to manage multiple projects and timelines and build cross-functional relationships
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, Dental & Vision
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.