Engineer, Device Engineering

Scorpion Therapeutics; San Diego (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics seeks a senior leader to own the drug-device combination program from concept through commercialization. You will set strategies and technical roadmaps, provide design controls expertise, and drive lifecycle management with cross-functional teams.

Responsibilities include leading human factors activities, authoring URRAs and DHF documents, and ensuring compliance with FDA/EU device regulations (ISO 14971, ISO 13485, EU MDR).

Qualifications

• Bachelor’s in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related.
• 8+ years’ experience in combination product or medical device development (end-to-end lifecycle).
• Experience with prefilled syringes and autoinjectors.
• Strong knowledge of subcutaneous drug delivery, device design, systems engineering, materials, and manufacturing.
• Experience implementing design controls and risk management; leading human factors/usability engineering.
• In-depth knowledge of FDA/EU regulations and quality systems (ISO 14971, ISO 13485, EU MDR).
• Experience with device characterization/design verification testing and contributing to regulatory submissions.
• Strong communication, stakeholder influence, and project management.

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 (formative and summative evaluations).
• Author/review human factors/usability plans, URRAs, study protocols/reports, and design control documentation.
• Provide expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing.
• Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
• Collaborate cross-functionally with Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs.
• Oversee external testing laboratories (device characterization/design verification).
• Establish/maintain design control processes and DHF documentation.
• Support design transfer (risk assessments, specifications, control strategies, statistical evaluation).
• Author/review combination product sections of INDs, IMPDs, BLAs, and MAAs.
• Ensure compliance with FDA/EU device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
• Identify technical/program risks, manage vendors/partners, and support continuous improvement.

Job description

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 (formative and summative evaluations).
• Author/review human factors/usability plans, URRAs, study protocols/reports, and design control documentation.
• Provide expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing.
• Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
• Collaborate cross-functionally with Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs.
• Oversee external testing laboratories (device characterization/design verification).
• Establish/maintain design control processes and DHF documentation.
• Support design transfer (risk assessments, specifications, control strategies, statistical evaluation).
• Author/review combination product sections of INDs, IMPDs, BLAs, and MAAs.
• Ensure compliance with FDA/EU device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
• Identify technical/program risks, manage vendors/partners, and support continuous improvement.

Requirements

• Bachelor’s in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related.
• 8+ years’ experience in combination product or medical device development (end-to-end lifecycle).
• Demonstrated experience with prefilled syringes and autoinjectors.
• Strong knowledge of subcutaneous drug delivery, device design, systems engineering, materials, and manufacturing.
• Experience implementing design controls and risk management; leading human factors/usability engineering.
• In-depth knowledge of FDA/EU regulations and quality systems (ISO 14971, ISO 13485, EU MDR).
• Experience with device characterization/design verification testing and contributing to regulatory submissions.
• Strong communication, stakeholder influence, and project management.

Preferred

• Advanced degree.
• Experience with biological drug products and primary packaging.
• cGMP process development, manufacturing controls, process risk assessments, design transfer.
• Fast-paced/high-growth biotech/pharma experience.
• Mentoring/technical leadership.