Regeneron is looking for a Sr. Device Development Engineer for our Combination Product Process Sciences team. This role will involve lab and non-lab work. They will support multiple cross- functional development teams and 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 Sr. Device Development Engineer, a typical day might include the following:
- Completes 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.
- Proficient in SolidWorks CAD modeling, creation of drawings, and an understanding of Geometric Dimensioning and Tolerancing (GD&T) practices.
- 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, raises 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 multi-functional team to assure project success.
- Have an in-depth understanding of Gage R&R and method validation techniques.
To be considered for the Sr. Device Development Engineer 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 Design Control (21 CFR 820 / ISO 13485) and ISO 14971 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)
$74,200.00 - $141,800.00
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What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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