Product Development Engineer

Job Description Responsibilities: Responsible for the research & development of best-in-class disposable infusion products. Responsible for understanding end-user needs, translating those into system requirements, developing robust design solutions, leading design verification and validation testing, and supporting design transfer to manufacturing and operations. Manage technical risks, drive feasibility testing, robustness testing, manage error budgets, cost models, and drive timely completion of projects. Requirements: BS/MS/PhD – Science/Engineering/Technology, Minimum of 5 years of hands-on design and development experience. Experienced in SolidWorks and mechanical design. Experienced in design control processes and creating and maintaining design control documentation. Strong engineering fundamentals, analytical ability, and problem-solving skills. Background and experience in Design of Experiments and statistical methods of analysis. Experienced in leading/working in cross-functional (R&D, marketing, sales, clinical, regulatory, operations etc.) environment toward effective collaboration and coordination Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971, IEC 60601, and collateral standards. Prior experience in medical device industry, medical device design controls, ISO standards. Prior experience in injection molding, plastic extrusion, DFM for high volume manufacturing. Experienced in requirements engineering, hazards analysis, FMEA/FTA, verification, and validation. Hands-on experience with Design for Six Sigma (DFSS) and Critical Parameter Management tools. Experience in modeling, simulations, and sensitivity analysis. : 22-00722 : San Diego, CA: