Job Description

Staff NPI Manufacturing Engineer

Client:

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 Senior/Staff 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 equipment
• Design and prototype novel manufacturing equipment and fixturing
• Create and maintain necessary Manufacturing Process Instructions (MPI’s), test methods, product drawings, and component specifications
• Upgrade our manufacturing processes to ensure proper DFM and maximum scalability of our medical devices
• Initiate and implement programs to continuously improve quality, cost and cycle time
• Prototype 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 defects
• Build the assembly line for our clinical launches
• Specify, 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 Engineering
• 5+ years of work experience
• Demonstrated 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 design
• Possess knowledge of process validation, GMP, and state-of-the-art manufacturing processes
• A driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.
• Solid understanding of design controls
• Demonstrated success developing catheter manufacturing processes including braiding, coil winding, extruding, lamination, adhesive joining, die bonding, and laser welding.

PREFERRED QUALIFICATIONS

• Experience with disposables/consumables
• Experience 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

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