Senior Device Development Engineer — Lead Device Delivery

Scorpion Therapeutics; Town of East Greenbush (NY); On-site; USD 120,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Sr. Device Development Engineer to drive end-to-end development of a device combination product and/or platform delivery system.

You will lead multidisciplinary teams through the design lifecycle, balance user needs with technical constraints, and define detailed specifications across commercial, clinical, and strategy collaborators. You will own validation of user needs, manage development programs, and ensure DHF compliance with 21 CFR Part 3 and 820.30,

Qualifications

• B.S. in Engineering and 5+ years of relevant experience (or equivalent education/experience).
• Prior product management and/or project leadership experience is required.
• Knowledge of relevant FDA regulations, especially 21 CFR Part 3 and 21 CFR 820.30.

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.
• Own user needs/requirements to be validated through design and development.
• Develop, manage, and communicate development program plans, risks, timelines, and budgets.
• Ensure a compliant Design History File (DHF) meets 21 CFR Part 3 and 21 CFR 820.30 requirements.

Skills

Project management

Cross-functional collaboration

Regulatory compliance

FDA regulations knowledge

Problem-solving

Education

Bachelor's degree in Engineering

Job description

Scorpion Therapeutics is seeking a Sr. Device Development Engineer to drive end-to-end development of a device combination product and/or platform delivery system.

You will lead multidisciplinary teams through the design lifecycle, balance user needs with technical constraints, and define detailed specifications across commercial, clinical, and strategy collaborators. You will own validation of user needs, manage development programs, and ensure DHF compliance with 21 CFR Part 3 and 820.30,