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Device Development Lead

New

Skills

Biologic/device combination product development Cross-functional team leadership Design Inputs Human factors engineering ISO 13485 knowledge Quality management systems Regulatory compliance (21 CFR Part 4) Test method development User Requirement Specifications (URS) Verification plans

We are seeking an Associate Director of Device Development to lead cross-functional teams in the innovative development of biologic/device combination products. This role is pivotal in ensuring the successful integration of device technology with biologics, driving quality management systems, and executing human factors strategies.

Key Responsibilities
  • Lead cross-functional teams in the development of biologic/device combination products.
  • Collaborate with Quality to refine the combo product quality management system.
  • Author User Requirement Specifications (URS), Design Inputs, and verification plans.
  • Oversee test method development and validation at external labs.
  • Establish human factors strategies and conduct HF studies.
  • Work with Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) to meet development, manufacturing, and supply goals.
Requirements & Qualifications
  • 10+ years of relevant industry experience.
  • BS in Mechanical, Biomedical, or Chemical Engineering; advanced degree is a plus.
  • Hands-on experience with biologic/device combo product development (prefilled syringe, autoinjector).
  • Familiarity with D&D documentation: URS, Design Inputs, and V&V plans.
  • Regulatory knowledge including 21 CFR Part 4 and ISO 13485.
  • Experience with CMOs/CROs and external device suppliers.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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