Senior Product Development Engineer

A Product Development Engineer (Level Senior) is responsible in developing new technologies, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team leading technically and cross functionally, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.NOTE: This position is an onsite position with a hybrid arrangement (currently 3 days/week in office and 2 days/week remote.  Candidates must be able to report to the office weekly.Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.Select techniques to solve complex problems and make sound design recommendations.Designs and prepare complex reports to communicate results to technical community.Designs and coordinates complex engineering tests and experiments.Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.Interfaces with Physicians/Lab personnel to obtain feedback on concepts and performance of new devices.Works cooperatively with operation, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.May train and/or provide work directions to interns, technicians and entry-level engineers.Fully participates in and successfully contributes to project teams including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.Perform product verification and validation testing, to ensure high-quality results and compliance with industry standards.Develop and maintain detailed product technical specifications, engineering drawings, and bill of materials (BOM).Designs, procures, and fabricates tooling and fixtures.Performs troubleshooting on new products/process problems related to design, material, or process.Collaborate with suppliers and vendors to source materials and components for product development.Evaluate and incorporate feedback from customers, end-users, key opinion leaders (KOL) and other stakeholders to improve product designs.Lead inter-disciplinary technical reviews intended to provide a systematic assessment of design results, device design and Design for Manufacturability (DFM). Create, draft and release technical reports required for product/process development programs. Lead the design knowledge transfer of new manufacturing processes and provide training to product builders and technicians.Establish and maintain appropriate design controls documentation, design trace matrices, design history files, technical files and device master records. Develop and execute required validations per QMS requirements to include Equipment, Process & Product validations.