Associate Sustaining Engineer

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 68,000 - 106,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Sustaining Engineer to join the sustaining engineering group, supporting our commercial combination products in a hybrid role.

The role focuses on monitoring and improving product quality and performance while collaborating with cross-functional design teams and key business partners. The position involves CAPA investigations, design change assessments, change management, and regulatory notifications, with a Monday–Friday 8–4:30 schedule.

Qualifications

• 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

Responsibilities

• Participate in manufacturing investigations and 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

Skills

CAPA resolutions

Design changes

Regulatory notifications

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Job description

Team: Industrial Operations & Product Supply

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:

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

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
• 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. 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)

$67,500.00 - $105,700.00

What people ask before they join

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

Our hiring process

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

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