Senior Device Engineer I

Job Title: Senior Device Engineer I Location: Foster City, CA ~3 days/week depending on team schedule, flexible but Tues-Thurs likely on site 18 mo. contract DescriptionThe Device Development and Clinical Packaging Engineering department is seeking a qualified Senior Device Engineer I to drive commercial readiness and life cycle management of drug- device combination products.This individual will be responsible for supporting manufacturability assessments, design verification builds, clinical builds, and design transfer and commercialization activities.This role requires expertise in process development, design controls, product/technology transfer, and process validation.ResponsibilitiesPerform product and process characterization studies and manufacturability assessments during design and development.Represent Device Engineering on late-stage device project teams.Lead design transfers to internal and external manufacturing sites, select and specify manufacturing equipment, and author/review design control documents.Drive clinical and commercial change records and support complaints investigations and deviations.Support risk management activities per ISO 14971.Support design verification and clinical product manufacturing builds.Support manufacturing site selection activities.Support equipment qualification and process validation activities.Knowledge & SkillsExperience and knowledge with medical device and combination product development and manufacturing including process validation and related global regulatory requirements.Experience with design, execution, and statistical analysis of process characterization studies.Experience with root cause analysis, deviation management, and investigations.Experience working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment.Strong verbal, written, and interpersonal communication skills are required.Must be able to write clear, concise, and error-free documents.Education & ExperienceA Bachelor’s Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of eight (8) years of relevant industry experience,OR a Master’s Degree and a minimum of six (6) years of relevant industry experience.