Device/Combination Product Manager
Viking Therapeutics, Inc.
August 06, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Marketing
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.
- 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.