Sr. Device Development Engineer- Product Design

BioSpace; Town of East Greenbush (NY); On-site; USD 66,000 - 144,000; Full time

Job summary

Regeneron is seeking a Device Development Engineer to join the Combination Drug Product Development group in East Greenbush, NY. The role focuses on designing innovative specialty drug delivery devices and leading development projects from concept through clinical and commercial stages.

Responsibilities include design transfer, secondary packaging, and collaborating with cross-functional teams to ensure robust and compliant products.

Qualifications

• BA/BS in Engineering or a related field.
• Associate Engineer: BS in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or similar.
• Engineer: BS in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or similar with 2+ years in product development.
• Sr. Engineer: BS in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or similar with 5+ years in product development.
• Experience in the medical device industry and 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.

Responsibilities

• Lead or support development projects for combination products, covering design, transfer, and packaging.
• Develop next-generation injection devices and related capabilities.
• Collaborate with program management to plan tasks from concept to clinical and commercial launches.
• Perform design verification with tolerance analysis, FEA (ANSYS), and Excel-based tools.
• Coordinate with multi-functional teams to ensure project success.
• Assess risk areas and propose timely mitigation strategies.
• Ensure compliance with design controls and industry standards.
• Maintain continuous improvement to ensure safety, efficacy, and timely delivery.

Education

Bachelor of Science in Biomedical Engineering

Bachelor of Science in Mechanical Engineering

Bachelor of Science in Chemical Engineering

Bachelor of Science in Engineering (related field)

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 Regenerons 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 6


• 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

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. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)

$66,200.00 - $143,900.00