Engineer, Device Engineering

Role: Senior Engineer specializing in drug-device combination product development, supporting from early concept to commercialization and lifecycle management. Responsibilities include developing technical strategies, leading human factors engineering, overseeing design controls, risk management, and device characterization for prefilled syringes and autoinjectors. The role involves cross-functional collaboration with Product Development, Manufacturing, Quality, Regulatory, and Clinical teams, managing external vendors, and ensuring compliance with FDA and EU regulations, ISO standards, and design control processes. Requirements: Bachelor's in Biomedical, Mechanical, or Pharmaceutical Sciences; 8+ years in medical device or combination product development, with expertise in subcutaneous drug delivery systems and device design; experience in regulatory submissions and overseeing testing. Preferred qualifications include advanced degrees, experience with biologics and cGMP processes, and leadership experience. High-value specifics include focus on subcutaneous delivery devices, regulatory compliance (FDA, EU MDR), and development of combination products from concept through commercialization. Location: Wisconsin or California, with competitive salary ranges.