Engineer III

Job Title: Engineer III Location: Branchburg, NJ Duration: 2 Year (Potential Extension) Hybrid Onsite Schedule, in office Tue, Wed, Th, with the ability to be remote Mon, Fri. If business needs require on-site presence Mon/Fri it may be necessary. Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope. * Serve on project technical team, consisting of cross-functional resources including but not limited to R&D, PDS&T, Quality, Biocompatibility, and Regulatory. * Partner with R&D to identify user and technical product requirements for a medical device product. * With Technical Lead, Develop Design Verification & Validation strategy. o Support Design Verification (planning, fixture development, method development, test method validation, protocol development, and test execution). * Drive the creation and execution of protocols and reports. * Manage Design History File content. * Participate in prototyping activities to transform concepts into functional devices. * Perform laboratory testing, including independently designed experiments to further project goals. * Conduct statistical analyses using software such as MiniTab or JMP to evaluate data and support design decisions. * Ensure compliance with company and industry standards regarding safety, quality, and regulatory policies (including GxP). Qualifications: List required and preferred qualifications (up to 10). Include education, skills and experience. * Experience with new product development, including defining user and technical product requirements. * Experience with Design controls, including Design Verification & Validation strategy development and execution. * Experience with laboratory testing as well as subsequent data analysis using statistical methods. * Experience with medical device regulatory submissions. * Experience with biological-based products preferred. * Bachelor's Degree or equivalent education with 5 or more years of experience or Master's degree or equivalent education with 3 or more years of experience.