Regeneron is currently looking for a Device Development Engineer to join our technical lead team within Combination Product Development. This position includes lab and non-lab work. In this position, you will execute technical activities for combination products projects following design controls.
A typical day for a Device Development Engineer might include:
- Review of applicable regulatory guidance and standards to ensure appropriate regulatory compliance.
- Establishing Design Inputs and associated technical translation rationales derived from user needs and regulatory requirements.
- Conducting design verification and characterization/feasibility activities, including writing technical protocols and reports, establishing statistically appropriate acceptance criteria and sampling plans, coordinating sample builds and test execution.
- Drafting Design Outputs including drawings, specification documents, bills of materials etc.
- Identify key performance requirements and associated essential Design Outputs.
- Establishing recommended Control strategy (incoming, in-process, release and stability) for combination product.
- Providing technical oversight on Medical Device custom component manufacturing during development.
- Supporting review and/or preparation of technical documentation for regulatory submissions.
- Working closely with multi-functional teams 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.
- Ensuring work activities are conducted in a manner aligned with all applicable regulations and industry standards.
- Maintaining a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
- Representing IOPS (Industrial Operations Product and Supply) 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 and ISO 13485.
- Enjoy critical thinking, problem-solving, and implementing strategic improvements.
- Are eager to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions to challenges.
- Are able to establish and cultivate highly effective partnerships to support and advance project goals and objectives.
- Are willing to travel up to 10% annually.
To be considered for the 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 and a minimum of 1+ years of related experience. For various levels you must have the following:
- Associate Device Development Engineer: 1+ years
- Device Development Engineer: 2+ years
- Sr. Device Development Engineer: 5+ years
- Or equivalent combination of education and experience
Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) is required. Experience in drug delivery space is preferred. Level is determined based on qualifications relevant to the role.
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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.
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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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