Sr. Device Development Engineer- Product Design

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 66,000 - 144,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Device Development Engineer to join the Combination Drug Product Development group in East Greenbush, NY. You will lead or contribute to design of innovative specialty drug delivery devices advancing Regeneron's pipeline.

A typical day includes project leadership, technical product engineering, design transfer and secondary packaging, plus developing next-generation injection devices and planning tasks from concept to clinical launches.

Qualifications

• Bachelor of Science in Biomedical, Mechanical or Chemical Engineering or similar field.
• 2+ years of product development/engineering for Engineer level or 5+ years for Sr. Engineer.
• Experience with regulated medical devices and Design Control (21 CFR 820 / ISO 13485) and ISO 14971.

Responsibilities

• Implements combination product development projects on time, in scope and within budget.
• Support development of next-generation injection devices.
• Plan tasks from concept to clinical and commercial launches with program management.
• Vetting designs with calculation, FEA (ANSYS), and statistical tolerance stacking.
• Collaborate with multi-functional teams to ensure project success.
• Ensure products are technically robust and compliant with design controls.

Skills

FEA

Design transfer

SolidWorks

CAD

Engineering analysis

Project management

Education

BS in Biomedical Engineering

BS in Mechanical Engineering

BS 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
• Shift: Monday-Friday- 8-4:30pm
• Travel: 5% domestic, sometimes international

Discover Your Role

A typical day might include the following:

• 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

• 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

Preferred Qualifications

• Experience with design controls, tolerance stacking, molding/machining expertise
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971

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 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, and 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 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. 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.

Salary Range (annually)

$66,200.00 - $143,900.00