Sustaining Engineer (Medical Device)

Location
Rensselaer, NY
Posted
Oct 18, 2019
Ref
18000BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

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.

*Level to be determined based on qualifications relevant to the role*

Essential Duties and Responsibilities include, but are not limited to, the following:

• 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.

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

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to multi-task

• Ability to analyze and identify trends

• Develops and delivers effective presentations

• Problem-solving skills

• Ability to train others on basic systems and processes

• Strong written communication

• Ability to work in an ever-changing environment

• Critical thinking skills

#LI-KS1
Education and Experience:

• BS in Engineering and 2+ years or MS in Engineering and 1+ year experience in the combination device or medical device industry.

• 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.

• Experience writing technical documents such as impact assessments, technical memos, and other engineering documentation is required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.