Engineer, Device Engineering

Scorpion Therapeutics; Madison (WI); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Wisconsin pay range

Excellent benefits package

Job summary

Scorpion Therapeutics seeks a senior leader to develop and execute strategies/roadmaps for drug-device combination product programs, providing technical leadership from concept through commercialization and lifecycle management.

You will lead human factors/usability engineering, design controls, risk management, and cross-functional collaboration, ensuring FDA/EU compliance while advancing prefilled syringes, autoinjectors, and related delivery systems.

Qualifications

• BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related.
• 8+ years in combination product/medical device development; concept-to-commercialization/lifecycle.
• Experience commercializing prefilled syringes and autoinjectors.
• Knowledge of subcutaneous delivery systems, device design, systems engineering, materials, manufacturing.
• Experience with design controls, risk management, human factors/usability engineering.
• Knowledge of FDA/EU regulations/quality systems (ISO 14971, ISO 13485, EU MDR).
• Experience with device characterization/design verification testing and device regulatory submission content.
• Strong communication, cross-functional influence, and project management.

Responsibilities

• Develop and execute strategies/roadmaps for drug-device combination product programs.
• Provide technical leadership from concept through commercialization and lifecycle management.
• Lead human factors/usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
• Lead formative/summative human factors evaluations and interpret results.
• Provide technical expertise in drug delivery technologies, device/system engineering, design controls, risk management, materials, and manufacturing processes.
• Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
• Collaborate cross-functionally (Product Development, Packaging, Manufacturing, Clinical, Supply Chain, Commercial, Quality, Regulatory).
• Oversee external testing labs; establish/maintain design control processes and DHF documentation.
• Support design transfer (risk assessments, specs, control strategies, statistical evaluation).
• Author/review combination-product regulatory submission sections (IND/IMPD/BLA/MAA).
• Ensure compliance with FDA/EU requirements and standards (ISO 14971, ISO 13485, EU MDR); manage risks and vendors.

Skills

Combination product development

Cross-functional leadership

Regulatory submissions

Human factors engineering

Design controls

Risk management

Project management

Communication

Education

BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related

Job description

Responsibilities:

• Develop and execute strategies/roadmaps for drug-device combination product programs.
• Provide technical leadership from concept through commercialization and lifecycle management.
• Lead human factors/usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
• Lead formative/summative human factors evaluations and interpret results.
• Provide technical expertise in drug delivery technologies, device/system engineering, design controls, risk management, materials, and manufacturing processes.
• Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
• Collaborate cross-functionally (Product Development, Packaging, Manufacturing, Clinical, Supply Chain, Commercial, Quality, Regulatory).
• Oversee external testing labs; establish/maintain design control processes and DHF documentation.
• Support design transfer (risk assessments, specs, control strategies, statistical evaluation).
• Author/review combination-product regulatory submission sections (IND/IMPD/BLA/MAA).
• Ensure compliance with FDA/EU requirements and standards (ISO 14971, ISO 13485, EU MDR); manage risks and vendors.

Requirements:

• BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related.
• 8+ years in combination product/medical device development; concept-to-commercialization/lifecycle.
• Experience commercializing prefilled syringes and autoinjectors.
• Knowledge of subcutaneous delivery systems, device design, systems engineering, materials, manufacturing.
• Experience with design controls, risk management, human factors/usability engineering.
• Knowledge of FDA/EU regulations/quality systems (ISO 14971, ISO 13485, EU MDR).
• Experience with device characterization/design verification testing and device regulatory submission content.
• Strong communication, cross-functional influence, and project management.

Preferred:

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

Compensation/Benefits:

• Wisconsin pay range: $120,000–$145,000; California pay range: $135,000–$155,000.
• Competitive salaries and an excellent benefit package.