Hiring: Senior Engineer, Device Development Company: Vaxcyte Location: San Carlos, CA Job Posted Time: 2026-09-11 10:36:35 Employment Type: On-site About the job Experience: •PhD with 5+ years, Masters with 10+ years, or BS with 13 + years of relevant industry experience in the development and manufacturing of injectable combination products. Other combinations of education and/or experience may be considered. •5+ years, Masters with 10+ years, or BS with 13 + years of relevant industry experience in the development and manufacturing of injectable combination products. Other combinations of education and/or experience may be considered. Required Skills: •Lead combination product and device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch, and post-market surveillance. •Guide the DP Technical Team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and 21 CFR Part 820.3, ensuring alignment and integration within established Combination Product program plans. •Develop and maintain design control documents and maintain the Design History File (DHF) and Device Master Record (DMR) for the VAX-31 PFS product. •Partner cross-functionally with internal cross-functional teams and external partners to execute device-specific plans to ensure program milestones are met. •Manage suppliers, device testing labs, and Human Factors Engineering partners to ensure successful design verification and validation studies. •Actively facilitate and support DP Technical Team in existing and new tech transfer activities for both early- and late-stage programs to CMOs. •Contribute to device-related submission strategies and support regulatory CMC activities •Mentor other engineers in the department, potentially leading to management opportunities. Qualifications: •The candidate should have significant experience in managing and executing Design Control programs with biological molecules for combination products, preferably PFSs. •Preferred experience in late-stage DP development, design and execution of PPQ protocols, and robust, reproducible, regulatory-compliant drug product manufacturing processes. Includes experience conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs. •The candidate should have a track record of working seamlessly within and across teams and organizations to execute Design Control processes. •Strong scientific leadership is required, including critical thinking, the ability to present complex data sets, and the ability to independently propose and design follow-up studies. •Strong interpersonal skills, including the ability to communicate effectively in both verbal and in written formats, in order to collaborate effectively within the DP Technical Team and across teams. •Senior Director, Device Development and Commercialization Lead Compensation: •$165,000 - $192,000 / year •Competitive benefits and rewards package •The compensation package will be competitive and includes comprehensive benefits and an equity component Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!