Device/Combination Product Manager

Scorpion Therapeutics; United States; On-site; USD 110,000 - 135,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced leader to serve as the internal technical lead for medical device and drug-device combination products, such as prefilled syringes and autoinjectors. You will own design controls, risk management, and design history files across the lifecycle.

You will partner cross-functionally with CMC, Quality, Regulatory Affairs, and Clinical teams to ensure on-time delivery and successful submissions, leveraging deep knowledge of 21 CFR parts, ISO standards, and

Qualifications

• Hands-on development of drug-device combination products from concept through commercialization.
• Working knowledge of 21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, IEC 62366-1, ISO 10993.
• Experience with design controls, DHF, V&V, and human factors/usability.
• Experience managing external device suppliers, CMOs, and CDMOs.
• Experience authoring device/combination product regulatory sections with Regulatory Affairs.
• Parenteral/injectable delivery experience; peptide/GLP-1/GIP plus cold-chain considerations is a plus.

Responsibilities

• Serve as internal technical lead and SME for medical device and drug-device combination product development (e.g., prefilled syringes, autoinjectors, pen injectors).
• Establish/maintain design control processes (21 CFR 820.30, ISO 13485) and the Design History File (user needs, design inputs/outputs, reviews, verification/validation).
• Lead risk management (ISO 14971), including hazard analysis, design/use FMEAs, and benefit-risk throughout the lifecycle.
• Direct human factors/usability engineering (IEC 62366-1; FDA human factors guidance), including formative/summative studies and risk analysis; develop instructions for use.
• Oversee external suppliers/CMOs/CDMOs: design transfer, component qualification, biocompatibility (ISO 10993), and manufacturing/assembly controls.
• Author/review device & combination product sections of IND/CTA/NDA/BLA submissions (21 CFR Part 4 cGMP) and support health authority responses with Regulatory Affairs.
• Define device specs, performance requirements, acceptance criteria, and control strategies; support CQA/testing for container-closure, extractables/leachables, and device performance.
• Partner cross-functionally with CMC, Drug Product, Quality, Regulatory Affairs, Clinical, and Supply Chain for on-time deliverables.

Skills

Drug-device development

Design controls

Regulatory knowledge

Human factors/usability

Supplier management

Technical leadership

Parenteral/injectable delivery

Education

BS in Biomedical/Mechanical Engineering or related

MS in related field

Job description

Responsibilities:

• Serve as internal technical lead and SME for medical device and drug-device combination product development (e.g., prefilled syringes, autoinjectors, pen injectors).
• Establish/maintain design control processes (21 CFR 820.30, ISO 13485) and the Design History File (user needs, design inputs/outputs, reviews, verification/validation).
• Lead risk management (ISO 14971), including hazard analysis, design/use FMEAs, and benefit-risk throughout the lifecycle.
• Direct human factors/usability engineering (IEC 62366-1; FDA human factors guidance), including formative/summative studies and risk analysis; develop instructions for use.
• Oversee external suppliers/CMOs/CDMOs: design transfer, component qualification, biocompatibility (ISO 10993), and manufacturing/assembly controls.
• Author/review device & combination product sections of IND/CTA/NDA/BLA submissions (21 CFR Part 4 cGMP) and support health authority responses with Regulatory Affairs.
• Define device specs, performance requirements, acceptance criteria, and control strategies; support CQA/testing for container-closure, extractables/leachables, and device performance.
• Partner cross-functionally with CMC, Drug Product, Quality, Regulatory Affairs, Clinical, and Supply Chain for on-time deliverables.

Requirements:

• BS (Biomedical/Mechanical Engineering or related) with 10+ years, or MS with 8+ years, in medical device and/or combination product development.

Knowledge/Skills:

• Hands‑on development of drug‑device combination products from concept through commercialization.
• Working knowledge of 21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, IEC 62366-1, ISO 10993.
• Experience with design controls, DHF, V&V, and human factors/usability.
• Experience managing external device suppliers, CMOs, and CDMOs.
• Experience authoring device/combination product regulatory sections with Regulatory Affairs.
• Parenteral/injectable delivery experience; peptide/GLP-1/GIP plus cold-chain considerations is a plus.
• Strong written/verbal communication and ability to influence stakeholders.

Salary:

$110,000.00–$135,000.00 annual salary.