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.

• 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.

• 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.