Staff Manufacturing Engineer, NPI

Staff NPI Manufacturing EngineerClient:Our client is an innovative, venture capital-funded medical device startup in Burlingame, CA. Their team is building something unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy.POSITION SUMMARY:The SeniorStaff Process Development Engineer will focus on further developing our product and then transferring it into a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful process, tooling and equipment design. This role will engage in cross-functional collaboration to accelerate the product development process, reduce cost of goods, and enable more complex designs through manufacturing improvements.ROLES AND RESPONSIBILITIES Work with product development to design and prototype novel manufacturing processes and equipmentDesign and prototype novel manufacturing equipment and fixturingCreate and maintain necessary Manufacturing Process Instructions (MPI's), test methods, product drawings, and component specificationsUpgrade our manufacturing processes to ensure proper DFM and maximum scalability of our medical devicesInitiate and implement programs to continuously improve quality, cost and cycle timePrototype fixtures using 3-D printers, lathe, drill press, band saw, etc.Provides technical support and performing failure analysis for non-conforming components, assemblies, and process defectsBuild the assembly line for our clinical launchesSpecify, support and maintain the proper CER space to manufacture our medical devices under defined environmental quality controls.Manage the flow of WIP through Lean practices including Kanban and 5S.Maintain relationships with key vendors and suppliers and support supplier validations and supplier management best practices.Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure GMP.Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic regulations including Cal FDB, OSHA and Cal-OSHA.REQUIRED QUALIFICATIONS B.S. or M.S. in Mechanical or Related Engineering5+ years of work experienceDemonstrated experience working with cross functional teams.Proven track record of generating and managing manufacturing documentation from concept to commercialization for medical device product (MPIs, LHRs, BOM, flowcharts, etc.)Capable with CAD modeling, engineering drawing generation, DFM, tolerance analysis and tooling designPossess knowledge of process validation, GMP, and state-of-the-art manufacturing processesA driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.Solid understanding of design controlsDemonstrated success developing catheter manufacturing processes including braiding, coil winding, extruding, lamination, adhesive joining, die bonding, and laser welding.PREFERRED QUALIFICATIONS Experience with disposablesconsumablesExperience managing lab technicians and assemblers.Developed products from invention to market release.Experience in a start-up environment.Proficient with SolidWorks.Experience creating and managing schedules, budgets, and plans.Experience with packaging and shipping validations

Created: 2025-02-21