Full-Time
NPI Process Development Engineer
Endoscopy
Posted on 4/18/2024
Develops flexible robots for endoscopy procedures
Mid, Senior
Burlingame, CA, USA
- B.S. or M.S. in Mechanical or Related Engineering
- 3+ years of work experience (5+ for senior)
- Demonstrated experience working with cross functional teams
- Generated and managed manufacturing documentation for a commercial 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
- Experience working on design controls and equipment/fixturing qualifications, including IQ/OQ/PQ
- Work with product development to design and prototype novel manufacturing processes and equipment
- Design and prototype novel manufacturing equipment and fixturing, and perform qualification activities as required
- Procure and implement off the shelf manufacturing equipment and fixturing, and perform qualification activities as required to support product development team
- 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
- Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
- Build the assembly line for our clinical launches
- Identify new potential vendors and suppliers, and maintain relationship with existing vendors and suppliers
- Support the assembly line for our clinical launches
- 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
- Other responsibilities to support NPI/PD manufacturing deliverables as needed
Triton Medical Robotics, a division of Neptune Medical, is pioneering advancements in medical robotics with a focus on enabling more precise and deep-reaching flexible endoscopy procedures. This focus not only sets a new standard in medical outcomes but also positions the company as a leader in the medical technology field. The integration of cutting-edge robotics into flexible endoscopy exemplifies the dedication to improving patient care, making it an exemplary workplace for those passionate about innovative healthcare solutions.
Company Stage
N/A
Total Funding
N/A
Headquarters
Burlingame, California
Founded
2016