Device Development Engineer
We are currently looking to fill a Device Development Engineer position. In this position you will execute combination products projects with responsibilities in Design Controls and technical product engineering.
A typical day for an 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, ISO 14971, 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.
To be considered for this role you must have a Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Electrical Engineering or a similar field and 3+ years of experience in product development or engineering is required or equivalent combination of education and experience. Experience in the medical device industry is required. Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
To be considered as a Senior Engineer level role, you must have a Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Electrical Engineering or a similar field and 5+ years of experience in product development or engineering is required or equivalent combination of education and experience.
Up to 20% travel is required for this role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.