Engineer, Device Engineering

Responsibilities Develop and execute strategies and technical roadmaps for drug-device combination product development. Provide technical leadership from concept through commercialization and lifecycle management. Lead human factors and usability engineering activities, including authoring/reviewing plans, usability risk assessments (URRAs), study protocols/reports, and design control documentation. Lead and support formative/summative human factors evaluations and interpret results. Provide technical expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing processes. Lead development of prefilled syringes, autoinjectors, and other drug delivery systems. Partner cross-functionally (Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, Regulatory Affairs). Oversee external testing laboratories and author/review protocols and reports. Establish/maintain design control processes and Design History File (DHF) documentation. Support design transfer (process risk assessments, specifications, control strategies, statistical evaluation). Author/review combination product sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs). Ensure compliance with FDA/EU medical device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR). Identify technical/program risks and manage mitigation; manage vendors/partners. Manage multiple projects/priorities; support continuous improvement. Requirements Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related field. 8+ years in combination product or medical device development (concept to commercialization/lifecycle). Demonstrated experience developing/commercializing prefilled syringes and autoinjectors. Strong knowledge of subcutaneous drug delivery systems; device design, systems engineering, materials, and manufacturing. Experience implementing design controls and risk management. Human factors/usability engineering experience (formative/summative; URRAs; plans/protocols/reports). In-depth knowledge of FDA/EU regulations, quality systems, and standards (ISO 14971, ISO 13485, EU MDR). Experience with device characterization and design verification testing. Experience contributing to device-related regulatory submissions. Proven vendor/partner management; excellent communication; ability to influence across functions; strong organization/project management. Preferred Advanced degree. Experience with biological drug products and primary packaging. cGMP process development, manufacturing controls, process risk assessments, and design transfer. Experience in fast-paced/high-growth biotech/pharma. Mentoring/technical leadership. #J-18808-Ljbffr Scorpion Therapeutics