Engineer, Device Engineering

Role: Senior Engineer leading device and combination product development at an innovative biopharma focused on RNAi therapeutics. Responsibilities: strategize and execute development from early concept to commercialization, with emphasis on drug delivery systems such as prefilled syringes and autoinjectors; lead human factors and usability studies; oversee design controls, risk management, and regulatory submissions; manage external testing labs and vendor relationships; ensure compliance with FDA, EU, ISO standards, and lifecycle management. Requirements: Bachelor's in Biomedical, Mechanical, or related engineering/sciences; 8+ years in medical device or combination product development supporting products through all phases; expertise in subcutaneous delivery devices, design controls, human factors engineering, and regulatory submissions; strong project management and cross-functional collaboration skills. Preferred: advanced degree, experience with biologics or cGMP processes, high-growth biotech experience, technical leadership or mentorship. High-Value: focus on drug-device combination products, early to late-stage development, regulatory compliance, human factors engineering, and cross-functional stakeholder engagement. WorkSetup: location-specific (Wisconsin or California), with no travel specified.