Senior Device Development Engineer (Project Leadership)

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.