Associate Sustaining Engineer

Regeneron Pharmaceuticals, Inc.; New York; On-site; USD 68,000 - 106,000; Full time

Benefits offered by this job

Annual bonuses or other incentive plan

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Sustaining Engineer to join our sustaining engineering group in East Greenbush, NY.

The role supports commercial combination products in a hybrid on-site capacity, focusing on monitoring and improving product quality while collaborating with cross-functional teams. You will participate in CAPA investigations, perform design change assessments, and help manage regulatory notifications.

Qualifications

• Bachelor's degree in Engineering (mechanical or biomedical helpful).
• Experience in medical/device industry and sustaining engineering preferred.
• Experience writing technical documents such as impact assessments and memos.

Responsibilities

• Participate in manufacturing investigations and CAPA resolutions to improve processes.
• Perform design change assessments and technical evaluations incl. supplier, label, and component changes.
• Implement design changes to improve product quality and customer experience.
• Maintain design history files and Risk Management Files using post-market surveillance data.
• Manage change and regulatory notifications; implement changes from complaints.
• Facilitate design transfer of existing products to new manufacturing sites.
• Participate in cross-functional design teams and build business partner relationships.

Skills

Technical writing

Regulatory knowledge

Cross-functional collaboration

Project management

Education

Bachelor's degree in Engineering

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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: East Greenbush, NY, United States
Shift: Monday- Friday- 8-4:30pm

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
• You 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

Salary and Benefits

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
• 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.

Equal Opportunity and Inclusion

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.

Background Checks

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.

On-site Requirements

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.

Salary Range (annually)

$67,500.00 - $105,700.00

For jobs in Canada: this posting is for an existing position.