Engineer, Device Engineering
Job in
Madison, Dane County, Wisconsin, 53774, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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.
- 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.
- Wisconsin pay range: $120,000–$145,000;
California pay range: $135,000–$155,000. - Competitive salaries and an excellent benefit package.
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