Sr. Device Development Engineer- Product Design

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 66,000 - 144,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Device Development Engineer to join the Combination Drug Product Development group in East Greenbush, NY. You will help design innovative drug delivery devices to advance Regeneron’s pipeline and improve patient access to medicines worldwide.

The role requires leading projects, ensuring design control compliance (21 CFR 820 / ISO 13485), and collaborating across multiple functions. Strong CAD/FEA skills and experience with regulated devices are preferred.

Qualifications

• Experience in the medical device industry and development of regulated devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971.
• Hands-on design and development of regulated medical devices with robust engineering analysis.
• Familiarity with design controls, tolerance stacking, molding/machining; experience with solid modeling tools.

Responsibilities

• Implements combination product development projects on time, in scope, and within budget.
• Lead design transfer and/or secondary packaging activities.
• Coordinate with program management to plan tasks from concept to clinical and commercial launches.
• Vet designs using calculation, FEA, and tolerance stacking with Excel and Sigmetrix Cetol 6σ.

Skills

Medical device industry experience

Regulatory awareness

Engineering fundamentals

Education

Bachelor of Science in Biomedical Engineering

Bachelor of Science in Mechanical Engineering

Bachelor of Science in Chemical Engineering

Tools

SolidWorks

CAD

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 Device Development Engineer to join our Combination Drug Product Development group!

In this role you will participate in and/or be the lead creative mind responsible for the design of innovative specialty drug delivery devices to address emerging needs in Regeneron’s product pipeline, advancing medications getting delivered to patients in need around the world.

When & Where

Location: East Greenbush, NY, United States

Shift: Monday-Friday- 8-4:30pm

Travel: 5% domestic, sometimes international

Discover your role

• Implements combination product development projects on time, in scope, and within budget with responsibilities in project leadership, technical product engineering, design transfer, and/or secondary packaging
• Support sophisticated solutions in developing next-generation injection devices
• Working with program management to identify and plan tasks vital to developing a project from concept to clinical and commercial launches
• Vetting designs with precise calculation, FEA (ANSYS), and statistical tolerance stacking with Excel and Sigmetrix Cetol 6σ
• Works closely with multi-functional team to assure project success
• Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably
• Identifies areas of project risk, mitigate issues and risks in an expedient manner, and actively proposes solutions
• Assures work activities are conducted in a manner aligned with all regulations and industry standards
• Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments

This role requires

• BA/BA in Engineering or a related field
• Associate Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field
• Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 2+ years of experience in product development or engineering
• Sr. Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 5+ years of experience in product development or engineering .
• Experience in the medical device industry and the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971.
• Experience with Solidworks, CAD, or similar
• Level is determined based on qualifications relevant to the role
• Experience with design controls, tolerance stacking, molding/machining expertise preferred
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 preferred

Does this sound like you?

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.

Salary Range (annually) $66,200.00 - $143,900.00

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.

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.

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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.