Job Description

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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