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Device Development Engineer



valley, al, usa · Valley, NE, USA
Posted on Saturday, June 29, 2024

Regeneron is currently looking for a Device Development Engineer for our Combination Product Process Sciences team. As an Engineer supporting multiple cross- functional development teams, this role will focus on the creation and validation of test methods used to assess the performance of various combination product device platforms. This position includes responsibilities in project leadership, technical product engineering, and timely transfer to our quality control teams.

As a Device Development Engineer, a typical day might include the following:

  • Executes 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.
  • Works partially in a laboratory environment with an understanding of the equipment used for functional and meteorological testing.
  • Understanding of Gage R&R, DOE, and statistical techniques used to assess combination product capability.
  • Develops and validates test methods used to evaluate the performance of various device platforms.
  • 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, escalates issues and risks in an expedient manner, and actively proposes solutions.
  • Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
  • Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
  • Represents IOPS and the devices group at appropriate industry meetings and forums.

This role might be for you if you:

  • Have experience with the practical application of Design Control concepts within FDA regulated industry including 21CFR820.30, ISO 13485 and ISO 14971.
  • You handle ambiguity well and can adapt quickly and motivate change based on new information.
  • Enjoying working closely with cross-functional team to assure project success.

To be considered for the Device Development Engineer role you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a B.S in Engineering; Biomedical Engineering, or Mechanical Engineering is preferred. For various levels you must have the following:

  • Device Development Engineer: 2+ years of relevant experience
  • Sr. Device Development Engineer: 5+ years of relevant experience

Prior experience in the medical device industry and working knowledge of applicable regulations is preferred. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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)

$72,800.00 - $139,100.00