Summary: Monitor, maintain, and/or improve 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.

Essential Duties and Responsibilities:

· Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes.

· Perform design change assessments for existing products.

· Implement design changes to improve the quality of existing products and/or the customer experience.

· Maintain Risk Management Files for existing products based on post market surveillance and manufacturing events.

· Facilitate design transfer of existing products to new manufacturing sites.

· Perform technical evaluations related to supplier and manufacturing changes to existing products.

· Participate in cross-functional design teams to address design issues.

· Develop and maintain key business partner relationships throughout IOPS so that sustaining engineering activities can proceed smoothly and support business practices.

Education and Experience:

· Associate Engineer: BS in Engineering.

· Engineer: BS in Engineering and 2+ year experience in the combination device or medical device industry or equivalent combination of education and experience. Experience writing technical documents such as impact assessments, technical memos, and other engineering documentation is required.

· Sr Engineer: BS in Engineering and 5+ year experience in the combination device or medical device industry or equivalent combination of education and experience. Experience writing technical documents such as impact assessments, technical memos, and other engineering documentation is required.

· Experience in the medical device industry is preferred.

· Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971 is preferred.

Knowledge, Skills, and Abilities:

· Strong technical writing and oral communication skills are required.

· Working knowledge of medical device regulatory requirements.

· Previous project management/sustaining engineering experience preferred.

· Ability to manage multiple projects and timelines.

· Ability to build strong working relationships cross-functionally

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)