Device / Combination Product Manager

Internal technical leader and subject-matter expert for medical device and drug-device combination product development across Viking Therapeutics’ pipeline. Partners with internal CMC, Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams, as well as external device suppliers, CMOs, and CDMOs, to execute phase-appropriate device and combination product activities from early development through late-stage clinical and pre-commercial readiness.

Responsibilities

• Serve as the internal subject-matter expert and technical lead for medical device and combination product development, including device constituent parts of drug-device combination products such as prefilled syringes, autoinjectors, and pen injectors.
• Establish and maintain design control processes (per 21 CFR 820.30 and ISO 13485) and the Design History File (DHF), including user needs, design inputs and outputs, design reviews, and design verification and validation.
• Lead device and combination product risk management activities in accordance with ISO 14971, including hazard analysis, design and use FMEAs, and benefit-risk assessment throughout the product lifecycle.
• Direct human factors and usability engineering programs (per IEC 62366-1 and applicable FDA human factors guidance), including formative and summative studies, use-related risk analysis, and instructions for use.
• Oversee device and combination product activities at external suppliers, device CMOs, and CDMOs, including design transfer, component qualification, biocompatibility (ISO 10993), and manufacturing and assembly controls.
• Author and review device and combination product sections of regulatory submissions (INDs, CTAs, NDAs/BLAs) consistent with 21 CFR Part 4 combination product cGMP requirements, and support responses to health authority questions in collaboration with Regulatory Affairs.
• Define device specifications, essential performance requirements, acceptance criteria, and control strategies; support container-closure, extractables and leachables, and device performance testing in partnership with Drug Product and Analytical Development.
• Partner cross-functionally with CMC, Drug Product, Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure integrated, phase-appropriate, on-time combination product deliverables.
• Provide device and combination product updates, risk assessments, and timelines at integrated project team meetings and to executive stakeholders, and 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.

Skills

• Demonstrated hands-on experience developing drug-device combination products (e.g., prefilled syringes, autoinjectors, pen injectors) from concept through commercialization, including design and integration of the device constituent part.
• Working knowledge of combination product and device regulations and standards, including 21 CFR Part 4, 21 CFR 820 (Quality System Regulation), ISO 13485, ISO 14971, IEC 62366-1, and ISO 10993.
• 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, including design transfer, component qualification, and delivery on time and within budget.
• Experience authoring device and combination product sections of regulatory submissions and supporting health authority interactions in collaboration with Regulatory Affairs.
• Experience with parenteral / injectable delivery systems and, ideally, peptide or GLP-1/GIP combination products and associated cold-chain considerations, is a plus.
• Strong written and verbal communication skills; ability to translate technical device matters into clear documentation and regulatory content, and to influence cross-functional and executive stakeholders.
• 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.

Pay

$110,000.00 - $135,000.00 annual salary