Engineer, Device Engineering

Role: Senior Engineer specializing in device and combination product development within biopharmaceuticals, focusing on drug delivery systems such as prefilled syringes and autoinjectors. Objectives include leading strategies, development, and lifecycle management of drug-device combinations from concept to commercialization. Responsibilities encompass technical leadership in device design, human factors engineering, risk management, regulatory compliance, and overseeing external testing and vendors. The role requires collaboration across R&D, manufacturing, clinical, regulatory, and quality teams to ensure products meet regulatory standards (FDA, EU MDR) and patient needs. Qualifications include a Bachelor's in Biomedical, Mechanical, or related engineering/sciences, 8+ years in medical device or combination product development, with proven expertise in drug delivery devices, design controls, risk management, and regulatory submissions. Preferred qualifications include an advanced degree, experience with biological products, cGMP processes, and mentoring. High-value specifics involve working on combination products in late-stage development or post-market, with emphasis on device characterization, verification, and compliance. The role is based in Wisconsin or California, with a competitive salary range and a focus on cross-functional leadership and external vendor management.