Regeneron

Associate Device Development Engineer- Technical Lead

RENSS - TECH VALLEY Full time

Regeneron is currently looking for Device Development Engineer to join our technical lead team within Process Sciences Drug Product Engineering. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies In this position, you will execute combination product projects with responsibilities in Design Controls and technical product engineering.

A typical day for a Device Development Engineer might include:

  • Working with project managers to execute projects on time, in scope, and within budget.
  • Working both independently and collaboratively with multi-functional teams to assure project success.
  • Supporting development activities, including Design Inputs, Design Outputs, Design Verification, Design Validation, Design transfer and risk management.
  • Ensuring that products being developed both internally and externally are technically robust through engineering analysis and perform sufficiently and reliably.
  • Assuring work activities are conducted in a manner in compliance with all regulations and industry standards.
  • Maintaining an environment of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
  • Representing our device group at appropriate industry meetings and forums.

This role might be for you if:

  • Have experience with the practical application of Design Control concepts within FDA regulated industry including 21CFR820.30 and ISO 13485.
  • You are a problem-solver, are willing to take action, self-starter.
  • You show eagerness to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions to challenges.
  • You will establish and cultivate highly effective partnerships with colleagues that support and advance project goals and objectives.
  • You can travel up to 10% annually.

To be considered for the Associate Device Development Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 0-2 years of related experience. Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$66,200.00 - $103,600.00