BioSpace
Associate Device Development Engineer- Technical Lead
BioSpace, East Greenbush, New York, United States
Associate Device Development Engineer- Technical Lead
Regeneron is currently looking for a Device Development Engineer to join our Technical Lead team within Process Sciences Drug Product Engineering. In this position you will execute combination product projects with responsibilities in Design Controls and technical product engineering.
Typical Responsibilities
Work with project managers to execute projects on time, in scope, and within budget.
Collaborate independently and with multi‑functional teams to assure project success.
Support development activities, including Design Inputs, Design Outputs, Design Verification, Design Validation, Design Transfer, and risk management.
Ensure that products being developed internally and externally are technically robust through engineering analysis and perform sufficiently and reliably.
Conduct work activities in compliance with all regulations and industry standards.
Maintain an environment of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
Represent our device group at appropriate industry meetings and forums.
Qualifications
Experience with Design Control concepts within FDA regulated industry, including 21CFR820.30 and ISO 13485.
Self‑starter who is willing to take action and solve problems.
Eager to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions.
Ability to establish and cultivate highly effective partnerships with colleagues to support project goals and objectives.
Travel up to 10% annually.
Employment Details Work Monday‑Friday, 8:00 am–4:30 pm. Bachelor of Science in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related field with 0–2 years of related experience. Preference for experience in regulated medical device or combination product development under Design Control (21 CFR 820 / ISO 13485) and ISO 14971.
Benefits We offer a comprehensive benefits package that varies by location, including health and wellness programs, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and eligible parental leave.
Equal Opportunity Regeneron is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, national origin, age, citizenship, disability, or any other protected characteristic in accordance with applicable laws.
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Typical Responsibilities
Work with project managers to execute projects on time, in scope, and within budget.
Collaborate independently and with multi‑functional teams to assure project success.
Support development activities, including Design Inputs, Design Outputs, Design Verification, Design Validation, Design Transfer, and risk management.
Ensure that products being developed internally and externally are technically robust through engineering analysis and perform sufficiently and reliably.
Conduct work activities in compliance with all regulations and industry standards.
Maintain an environment of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
Represent our device group at appropriate industry meetings and forums.
Qualifications
Experience with Design Control concepts within FDA regulated industry, including 21CFR820.30 and ISO 13485.
Self‑starter who is willing to take action and solve problems.
Eager to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions.
Ability to establish and cultivate highly effective partnerships with colleagues to support project goals and objectives.
Travel up to 10% annually.
Employment Details Work Monday‑Friday, 8:00 am–4:30 pm. Bachelor of Science in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related field with 0–2 years of related experience. Preference for experience in regulated medical device or combination product development under Design Control (21 CFR 820 / ISO 13485) and ISO 14971.
Benefits We offer a comprehensive benefits package that varies by location, including health and wellness programs, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and eligible parental leave.
Equal Opportunity Regeneron is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, national origin, age, citizenship, disability, or any other protected characteristic in accordance with applicable laws.
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