Research And Development Engineer

Project Engineer – Medical Device & Combination ProductsLocation: 100% RemoteDuration: 5-Month Contract (Potential Extension/ Conversion)Pay Rate: $96 - 100/hourPosition SummaryOur client is seeking an experienced Project Engineer to support medical device and combination product development activities. This role will focus on design control, risk management, verification testing, and regulatory support for device-related projects within a regulated environment.Key ResponsibilitiesLead and support device and combination product development activitiesManage design control documentation, DHF, risk assessments, and traceabilityDevelop and execute design verification testing and test methodsSupport regulatory submissions and compliance activitiesCoordinate with cross-functional teams, vendors, and CMOs/CDMOsSupport human factors engineering studies and manufacturing activitiesAuthor technical documents including protocols, reports, SOPs, and work instructionsDrive product and process improvements through change control processesRequired QualificationsBS in Engineering or related field required; MS preferred8–10+ years of medical device or combination product development experienceStrong experience with:Design controlsRisk management (DFMEA, PFMEA, UFMEA)Design verification & validationDHF documentationRegulatory standards (FDA, ISO, cGMP, QSR)Experience working with external vendors, CMOs, or CDMOsStrong communication and project coordination skillsPreferred ExperienceAuto injectors, prefilled syringes, needle safety devices, or on-body devicesHuman factors engineering supportDesign for Manufacturability (DFM) and Design for Assembly (DFA)SolidWorks or similar design software experience