Device Development Engineer
Regeneron
2 months ago
On-site
East Greenbush, NY
Clinical Research and Development
Device Development Engineer (Combination Product Development)
Responsibilities:
- Execute technical activities for combination product projects following design controls.
- Review applicable regulatory guidance and standards to ensure regulatory compliance.
- Establish design inputs and technical translation rationales derived from user needs and regulatory requirements.
- Conduct design verification and characterization/feasibility activities (write technical protocols/reports; define acceptance criteria and sampling plans; coordinate sample builds and test execution).
- Draft design outputs (drawings, specification documents, bills of materials, etc.).
- Identify key performance requirements and associated essential design outputs.
- Establish recommended control strategy (incoming, in-process, release, stability) for combination products.
- Provide technical oversight on medical device custom component manufacturing during development.
- Support review and/or preparation of technical documentation for regulatory submissions.
- Work closely with multi-functional teams to assure project success.
- Ensure internally/external products are technically robust via engineering analysis.
- Ensure work activities align with applicable regulations and industry standards.
- Maintain continuous improvement to support product safety and efficacy while accelerating delivery.
- Represent IOPS and the devices group at industry meetings/forums.
Qualifications / Requirements:
- Ability to work Monday–Friday, 8:00am–4:30pm.
- B.S. in Engineering.
- Experience developing regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) is required.
Preferred Skills / Experience:
- Biomedical engineering or mechanical engineering.
- Experience in drug delivery space.
- Practical application of Design Control concepts in FDA-regulated industry (21 CFR 820.30; ISO 13485).
- Critical thinking, problem-solving, and strategic improvement implementation.
- Ability to diagnose inefficiencies, resolve root causes, and recommend solutions.
- Ability to establish/cultivate effective partnerships.
- Willingness to travel up to 10% annually.
Education/Experience by Level:
- Associate Device Development Engineer: 0–2+ years
- Device Development Engineer: 2+ years
- Sr. Device Development Engineer: 5+ years
- Or equivalent combination of education and experience
Application Instructions:
- Apply now to take your first step towards living the Regeneron Way.
Benefits (if applicable):
- Comprehensive benefits vary by location; U.S. may include medical, dental, vision, life, and disability insurance, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Salary Range (annually):
- $66,200.00 - $123,300.00
Responsibilities:
- Execute technical activities for combination product projects following design controls.
- Review applicable regulatory guidance and standards to ensure regulatory compliance.
- Establish design inputs and technical translation rationales derived from user needs and regulatory requirements.
- Conduct design verification and characterization/feasibility activities (write technical protocols/reports; define acceptance criteria and sampling plans; coordinate sample builds and test execution).
- Draft design outputs (drawings, specification documents, bills of materials, etc.).
- Identify key performance requirements and associated essential design outputs.
- Establish recommended control strategy (incoming, in-process, release, stability) for combination products.
- Provide technical oversight on medical device custom component manufacturing during development.
- Support review and/or preparation of technical documentation for regulatory submissions.
- Work closely with multi-functional teams to assure project success.
- Ensure internally/external products are technically robust via engineering analysis.
- Ensure work activities align with applicable regulations and industry standards.
- Maintain continuous improvement to support product safety and efficacy while accelerating delivery.
- Represent IOPS and the devices group at industry meetings/forums.
Qualifications / Requirements:
- Ability to work Monday–Friday, 8:00am–4:30pm.
- B.S. in Engineering.
- Experience developing regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) is required.
Preferred Skills / Experience:
- Biomedical engineering or mechanical engineering.
- Experience in drug delivery space.
- Practical application of Design Control concepts in FDA-regulated industry (21 CFR 820.30; ISO 13485).
- Critical thinking, problem-solving, and strategic improvement implementation.
- Ability to diagnose inefficiencies, resolve root causes, and recommend solutions.
- Ability to establish/cultivate effective partnerships.
- Willingness to travel up to 10% annually.
Education/Experience by Level:
- Associate Device Development Engineer: 0–2+ years
- Device Development Engineer: 2+ years
- Sr. Device Development Engineer: 5+ years
- Or equivalent combination of education and experience
Application Instructions:
- Apply now to take your first step towards living the Regeneron Way.
Benefits (if applicable):
- Comprehensive benefits vary by location; U.S. may include medical, dental, vision, life, and disability insurance, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Salary Range (annually):
- $66,200.00 - $123,300.00