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About the Role

The Device / Combination Product Manager serves as the internal technical leader and subject-matter expert for medical device and drug-device combination product development. This role partners with internal teams and external suppliers to plan and execute phase-appropriate device and combination product activities from early development through pre-commercial readiness. The position is needed to fill a gap in internal expertise and bandwidth limitations, providing focused technical leadership and reducing reliance on external resources.

Responsibilities

Serve as the internal subject-matter expert and technical lead for medical device and combination product development.
Establish and maintain design control processes and the Design History File (DHF).
Lead device and combination product risk management activities.
Direct human factors and usability engineering programs.
Oversee device and combination product activities at external suppliers, device CMOs, and CDMOs.
Author and review device and combination product sections of regulatory submissions.
Define device specifications, essential performance requirements, acceptance criteria, and control strategies.
Partner cross-functionally to ensure integrated, phase-appropriate, on-time combination product deliverables.
Provide device and combination product updates, risk assessments, and timelines to stakeholders.
Help build internal device capability, processes, and governance.
Other duties as assigned.

Requirements

B.S. in Biomedical Engineering, Mechanical Engineering, a related engineering field, or a relevant scientific discipline, with 10+ years of medical device and/or combination product development experience in the pharmaceutical, biotech, or medical device industry; or M.S. with 8+ years; or an equivalent combination of education and experience.
Demonstrated hands-on experience developing drug-device combination products from concept through commercialization.
Working knowledge of combination product and device regulations and standards.
Experience establishing and managing design controls, Design History Files, design verification and validation, and human factors / usability engineering programs.
Track record of managing external device suppliers, CMOs, and CDMOs.
Experience authoring device and combination product sections of regulatory submissions and supporting health authority interactions.
Strong written and verbal communication skills.
Entrepreneurial mindset with the ability to thrive in a fast-paced, lean biotech environment.
Strong organizational skills, attention to detail, and the ability to build internal capability while managing multiple priorities and external partners simultaneously.

Skills

Medical device development
Combination product development
Design controls
Risk management
Human factors engineering
Usability engineering
Regulatory submissions
Supplier management
Communication skills
Organizational skills

Experience Level

10+ years of medical device and/or combination product development experience
8+ years of medical device and/or combination product development experience

Education Level

B.S. in Biomedical Engineering, Mechanical Engineering, a related engineering field, or a relevant scientific discipline
M.S.

Salary/Compensations

$110,000.00 - $135,000.00

About the Company

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Equal Opportunity

Viking Therapeutics, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.