Sr. Device Development Engineer (Project Leadership)
Regeneron
June 27, 2026
Remote friendly (East Greenbush, NY)
United States
Operations
Sr. Device Development Engineer — device combination product and/or platform delivery system within a therapeutic area.
Responsibilities:
- Lead multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing, Quality) through the device design and development lifecycle.
- Define detailed product requirements/specifications with commercial, clinical, and strategy collaborators.
- Define technical specifications/design requirements with engineering partners (manufacturing, verification, packaging).
- Own and ensure validation of user needs and requirements through design and development.
- Develop, manage, and communicate development program plans, risks, timelines, and budgets.
- Integrate device development activities with Chemistry Manufacturing Controls (CMC) and global timing/goals.
- Support internal and external manufacturing teams with relevant design and process development information transfers.
- Lead product testing and quality assurance processes for the specific device development.
- Ensure a compliant Design History File (DHF) meeting 21 CFR Part 3 and 21 CFR 820.30 requirements.
- Support related clinical/commercial regulatory activities (e.g., IND/IMPD, BLA submission, Clinical Pharmacy Manuals).
- Understand design inputs/outputs across delivery systems and impacts to end users.
- Support therapeutic area device leads on strategic product launch and go-to-market plans.
Qualifications:
- B.S. in Engineering and 5+ years relevant experience (or equivalent education/experience).
- Previous product/project management and/or project leadership experience.
Skills/Requirements:
- Knowledge of FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
- Experience with design history file management (21 CFR 820.30).
- Strong project management, interpersonal, analytical, and problem-solving skills.
- Ability to balance business objectives with technical constraints and work across functional teams.
- Willingness/ability to travel for partner meetings, audits, and coordination.
Application: Apply now.
Responsibilities:
- Lead multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing, Quality) through the device design and development lifecycle.
- Define detailed product requirements/specifications with commercial, clinical, and strategy collaborators.
- Define technical specifications/design requirements with engineering partners (manufacturing, verification, packaging).
- Own and ensure validation of user needs and requirements through design and development.
- Develop, manage, and communicate development program plans, risks, timelines, and budgets.
- Integrate device development activities with Chemistry Manufacturing Controls (CMC) and global timing/goals.
- Support internal and external manufacturing teams with relevant design and process development information transfers.
- Lead product testing and quality assurance processes for the specific device development.
- Ensure a compliant Design History File (DHF) meeting 21 CFR Part 3 and 21 CFR 820.30 requirements.
- Support related clinical/commercial regulatory activities (e.g., IND/IMPD, BLA submission, Clinical Pharmacy Manuals).
- Understand design inputs/outputs across delivery systems and impacts to end users.
- Support therapeutic area device leads on strategic product launch and go-to-market plans.
Qualifications:
- B.S. in Engineering and 5+ years relevant experience (or equivalent education/experience).
- Previous product/project management and/or project leadership experience.
Skills/Requirements:
- Knowledge of FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
- Experience with design history file management (21 CFR 820.30).
- Strong project management, interpersonal, analytical, and problem-solving skills.
- Ability to balance business objectives with technical constraints and work across functional teams.
- Willingness/ability to travel for partner meetings, audits, and coordination.
Application: Apply now.