Senior NPI Process Development Engineer

Neptune Medical•Burlingame, CA

19h•$140,000 - $175,000

About The Position

The Senior NPI 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. 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 platform.

Requirements

B.S. or M.S. in Mechanical or Related Engineering
4+ 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.

Nice To Haves

Experience with catheter or similar manufacturing (lamination, bonding, dip coating, ultrasonic welding, etc)
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

Responsibilities

Work with product development to design and prototype novel manufacturing processes and equipment
Develop new processes to manufacture our products to meet device performance and cost targets.
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.