Sr. Device Engineer

Location: Foster City, CAJob Title: Senior Device Engineer - Combination Products Sustaining EngineeringContract Length: 18-months, with possibility of extensionPay rate range: $105-115/hr, dependent on experienceDescriptionWe are seeking a highly motivated, detail-oriented Sr.

Device Engineer to support drug-devicecombination products across the commercial lifecycle. The successful candidate will supportcommercialization and sustaining engineering activities for combination drug/medical devices,from design transfer through ongoing commercial support. This role requires expertise indesign controls, risk management, change management, and complaint management.Specific Job ResponsibilitiesRepresent Device Development on commercial CMC and business continuity teams, and communicate technical findings and project updates clearly to project teams and stakeholders.Implement post-launch changes, support complaint handling and investigations, and investigate and close out deviations.Perform risk management reviews and updates in accordance with ISO 14971.Maintain the Design History File (DHF) throughout the commercial lifecycle.Support business continuity activities, including second sourcing.Support manufacturing site selection and other late-stage development activities.Execute design transfer activities to internal and external manufacturing sites.Author, review, and approve technical documentation, including design control records, test methods, protocols, reports, and risk management documentation.Knowledge & SkillsCandidates must have experience and knowledge in all of the following areas:Development and manufacturing of medical devices in accordance with ISO 13485.Risk management in accordance with ISO 14971.The candidate must have experience and knowledge in one or more of the following areas:Root cause analysis, deviation management, and investigations.Lifecycle change control management for combination products.Management of combination product-related complaints.Experience working with vendors, suppliers, and contract manufacturers to implement changes or investigate product and process performance issues.Design, execution, and statistical analysis of process characterization studies.Candidates with experience and knowledge in the following areas will be considered especially well qualified:Design transfer to internal and external manufacturing sites and partners.Familiarity with common mechanical assembly processes used in drug injection and delivery systems.Experience with Solidworks, Onshape, or Fusion 360.Familiarity with the requirements of ICH Q7, Q8, Q9, and Q10.Experience with project management methods and tools.Experience with basic statistical methods, including design of experiments, components of variance analysis, and statistical tolerancing.Education & Experience6+ years of relevant experience with a BS or BA in a related field; or 4+ years of relevant experience with an MS.