Senior Device and Combination Product Manager

Viking Therapeutics; San Diego (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a senior-level Device / Combination Product Director to lead device development across its pipeline. You will establish design controls, manage risk, and oversee external suppliers to ensure compliant, on-time delivery of drug-device products.

The role requires extensive experience with medical device regulations, human factors, and cross-functional collaboration, with compensation aligned to seniority in a biotech setting.

Qualifications

• 10+ years of medical device and/or combination product development experience.
• BS or MS in Biomedical Engineering or related field with relevant experience.
• Hands-on experience developing drug-device combination products.
• Knowledge of 21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, IEC 62366-1, ISO 10993.
• Experience managing external device suppliers, CMOs, and CDMOs.
• Strong written and verbal communication; able to translate device matters into regulatory content.
• Entrepreneurial mindset with ability to work in a fast-paced biotech environment.

Responsibilities

• Serve as internal SME and technical lead for device development across Viking’s portfolio.
• Establish and maintain design controls and the Design History File per applicable standards.
• Lead device risk management activities per ISO 14971.
• Direct human factors and usability engineering programs per IEC 62366-1.
• Oversee device activities at external suppliers, CMOs, and CDMOs.
• Author device sections of regulatory submissions and support health authority interactions.
• Define device specifications, performance requirements, and testing strategies.
• Collaborate with CMC, Drug Product, Quality, Regulatory Affairs, Clinical and Supply Chain.
• Provide device updates and timelines at IP meetings and with executives.

Skills

Device development

Regulatory submissions

Supplier management

Design controls

Human factors

Communication

Entrepreneurial mindset

Education

BS in Biomedical Engineering

MS in Biomedical Engineering

Job description

Viking Therapeutics, Inc. is seeking a senior-level Device / Combination Product Director to lead device development across its pipeline. You will establish design controls, manage risk, and oversee external suppliers to ensure compliant, on-time delivery of drug-device products.

The role requires extensive experience with medical device regulations, human factors, and cross-functional collaboration, with compensation aligned to seniority in a biotech setting.