Demo

Senior or Staff Manufacturing NPI Engineer - Catheters

Cambridge Recruiters
Burlingame, CA Full Time
POSTED ON 2/6/2025
AVAILABLE BEFORE 4/30/2025

JOB TITLE : Senior or Staff NPI Manufacturing Engineer, Catheters'

POSITION SUMMARY :

The Senior / Staff NPI Manufacturing 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.

The ideal candidate will act with passion and intensity in a medical device start-up that is fast paced and collaborative and will display the ability to perform to the requirements outlined below.

For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platfom.

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.
  • REQUIRED QUALIFICATIONS

  • B.S. or M.S. in Mechanical or Related Engineering
  • 5 years of work experience with a Medical Device Company
  • 3-5 years working on Catheter-Based devices, catheters, delivery systems.
  • MUST HAVE

    Demonstrated success developing

    catheter manufacturing processes

    including braiding, coil winding, extruding, lamination, adhesive joining, die bonding, and laser welding.

  • 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
  • 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
  • Office Location :

    Burlingame, CA, near the Millbrae Caltrain and BART station.

    Will consider H1B Transfer or Green Card Sponsorship candidates - YES.

    Local Candidates preferred, however will consider relocation for well-qualified candidates.

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