Device Development Lead

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.