Senior Device Development Engineer (Project Leadership)
Regeneron
August 19, 2026
On-site
East Greenbush, NY
Operations
Sr. Device Development Engineer (Device Combination Product / Platform Delivery System)
Responsibilities:
- Drive end-to-end development of a device combination product and/or platform delivery system within a therapeutic area.
- Lead multidisciplinary engineering 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 teams (manufacturing, verification, packaging, etc.).
- Own user needs/requirements to be validated through design and development.
- Develop, manage, and communicate development program plans, risks, timelines, and budgets.
- Integrate device development with Chemistry, Manufacturing & Controls (CMC) and global development timing/goals.
- Support internal and external manufacturing teams with relevant design and process information transfers.
- Lead product testing and quality assurance processes for the device development.
- Ensure a compliant Design History File (DHF) is developed and meets 21 CFR Part 3 and 21 CFR 820.30 requirements.
- Support related clinical/commercial regulatory activities (e.g., IND/IMPD, BLA submissions, clinical pharmacy manuals).
- Understand design inputs/outputs across delivery systems and impacts to end users.
- Support strategic product launch and go-to-market plans.
Qualifications:
- B.S. in Engineering and 5+ years of relevant experience (or equivalent education/experience).
- Prior product management/project management and/or project leadership experience required.
Skills/Requirements:
- Knowledge of relevant FDA regulations, especially 21 CFR Part 3 and 21 CFR 820.30.
- Experience with DHF management (21 CFR 820.30).
- Strong project management, interpersonal, analytical, and problem-solving skills.
- Ability to balance business objectives with technical constraints.
- Ability to work effectively across multiple functional teams.
- Willingness/ability to travel for partner meetings, audits, and project coordination.
Application Instructions:
- Apply now.
Responsibilities:
- Drive end-to-end development of a device combination product and/or platform delivery system within a therapeutic area.
- Lead multidisciplinary engineering 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 teams (manufacturing, verification, packaging, etc.).
- Own user needs/requirements to be validated through design and development.
- Develop, manage, and communicate development program plans, risks, timelines, and budgets.
- Integrate device development with Chemistry, Manufacturing & Controls (CMC) and global development timing/goals.
- Support internal and external manufacturing teams with relevant design and process information transfers.
- Lead product testing and quality assurance processes for the device development.
- Ensure a compliant Design History File (DHF) is developed and meets 21 CFR Part 3 and 21 CFR 820.30 requirements.
- Support related clinical/commercial regulatory activities (e.g., IND/IMPD, BLA submissions, clinical pharmacy manuals).
- Understand design inputs/outputs across delivery systems and impacts to end users.
- Support strategic product launch and go-to-market plans.
Qualifications:
- B.S. in Engineering and 5+ years of relevant experience (or equivalent education/experience).
- Prior product management/project management and/or project leadership experience required.
Skills/Requirements:
- Knowledge of relevant FDA regulations, especially 21 CFR Part 3 and 21 CFR 820.30.
- Experience with DHF management (21 CFR 820.30).
- Strong project management, interpersonal, analytical, and problem-solving skills.
- Ability to balance business objectives with technical constraints.
- Ability to work effectively across multiple functional teams.
- Willingness/ability to travel for partner meetings, audits, and project coordination.
Application Instructions:
- Apply now.