Senior Device & Combination Product Lead

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

Job summary

Viking Therapeutics, Inc. is seeking a Device / Combination Product Director to lead the device components of our drug-device products across the portfolio.

You will establish design controls and risk management, and ensure regulatory alignment from early development through late-stage clinical readiness. You will partner with CMC, Regulatory Affairs, Quality, Clinical, and Supply Chain to deliver phase-appropriate device deliverables while guiding external CMOs and CDMOs.

Qualifications

• Hands-on experience developing drug-device combination products from concept through commercialization.
• Experience with design controls, DHF, design reviews, and design verification/validation.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, IEC 62366-1 and ISO 10993.
• Experience managing external device suppliers, CMOs, and CDMOs with on-time delivery.
• Experience with regulatory submissions for combination products and collaboration with Regulatory Affairs.

Responsibilities

• Serve as internal SME and technical lead for medical device and combination product development across Viking’s portfolio.
• Establish and maintain design control processes and the Design History File.
• Lead risk management activities per ISO 14971, including FMEAs and risk assessment.
• Direct human factors and usability programs per IEC 62366-1 and FDA guidance.
• Oversee device activities at external suppliers and ensure compliance and transfer of designs.

Skills

Device development

Regulatory submissions

Risk management

Human factors

Cross-functional leadership

Design controls

External partner management

Communication

Education

BS in Biomedical Engineering

MS in related field

Job description

Viking Therapeutics, Inc. is seeking a Device / Combination Product Director to lead the device components of our drug-device products across the portfolio.

You will establish design controls and risk management, and ensure regulatory alignment from early development through late-stage clinical readiness. You will partner with CMC, Regulatory Affairs, Quality, Clinical, and Supply Chain to deliver phase-appropriate device deliverables while guiding external CMOs and CDMOs.