Senior Process Development Engineer

Position OverviewThe Senior NPI Engineer leads the validation and launch of new medical device products into manufacturing. This role ensures products are ready for production, meet quality and regulatory requirements, and can be scaled efficiently. The position works closely with R&D, Operations, Quality, Supply Chain, and customers to support successful product launches.Key ResponsibilitiesLead process validations (IQ, OQ, PQ) and statistical studiesSupport pilot builds and transfer products into productionDevelop and approve validation documentsLead risk assessments (DFMEA, PFMEA) and control plansSupport scale-up activities and production readinessDrive root cause investigations and CAPAOversee development of fixtures and validation equipmentTrain manufacturing teams on new processesEnsure compliance with FDA regulations and quality systemsMentor junior engineersQualificationsBachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field)6+ years of medical device experience (catheter experience preferred)Strong experience with IQ/OQ/PQ and statisticsKnowledge of GD&T and SolidWorksExperience working in FDA-regulated environmentsAdditional RequirementsAbility to work with microscopesAbility to lift up to 50 lbsTravel between sites as needed