Associate Director, Device Development (Biotech)

TL;DR

Associate Director, Device Development (Biotech): Leading the technical development of patient-centric drug delivery systems for biologic and combination product programs with an accent on prefilled syringes, autoinjectors, and needle safety devices. Focus on overseeing design verification, validation protocols, and collaborating with external CMOs/CROs to ensure commercial readiness.

Location: Fully remote within the United States

Salary: $180,000 – $200,000 USD

Company

A fast-growing biotechnology company focused on advancing innovative biologic and combination product programs.

What you will do

• Serve as the technical lead for the design, development, and commercialization of biologic/device combination products.
• Develop product realization documentation, including user requirements, design inputs, verification plans, and validation protocols.
• Oversee test method development and statistical analysis performed by external laboratories and manufacturing partners.
• Lead human factors engineering strategies and coordinate formative and summative studies.
• Collaborate with Quality teams to strengthen combination product quality systems and ensure cGMP compliance.
• Support technology transfer, process validation, and commercial readiness across external manufacturing sites.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering (advanced degree preferred).
• Minimum 10 years of experience in biotechnology, pharmaceutical, or medical device development.
• Hands-on experience with prefilled syringes, autoinjectors, needle safety devices, or on-body injectors.
• Strong expertise in design controls, verification and validation, and product transfer activities.
• Deep understanding of 21 CFR Part 4, 21 CFR 820, ISO 13485, and ISO 14971.
• Must be based in the United States.

Culture & Benefits

• Competitive salary with performance bonuses and equity grant participation.
• Comprehensive medical, health, welfare, and retirement benefits package.
• Generous paid time off, including three weeks of PTO, paid sick leave, and two company-wide shutdown weeks annually.
• Full remote work flexibility within the USA.
• Strong collaborative culture focused on professional growth and continuous learning.