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NPI Process Development Engineer, Endoscopy
4 months ago
Triton Medical Robotics, a division of Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Triton is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Ourrobot will disrupt flexible endoscopy and set a new standard in outcomes fordecades to come.
TITLE: NPI Process Development Engineer, Endoscopy
POSITION SUMMARY:
The 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.
ROLES AND RESPONSIBILITIES:
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
REQUIRED QUALIFICATIONS:
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
While not currently anticipated, this role may require occasional travel
PREFERRED QUALIFICATIONS:
Experience with disposables/consumables
Experience with development of articulating catheters/endoscopes
Experience with robotic catheters/endoscopes
Developed products from invention to market release
Experience in a start-up environment
Proficient with SolidWorks
Experience working with contract manufacturers
Experience working with 3D printers
Experience creating and managing schedules, budgets, and plans
Experience with packaging and shipping validations
Triton Robotics is located in Burlingame, CA, near the Millbrae Caltrain and BART station.
Our job titles may span more than one career level. The starting base salary for this role is between $120,000 and $165,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.
Triton Robotics provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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