Senior Manufacturing Engineer, Endoscopy

Neptune Medical•Burlingame, CA

4h•$140,000 - $175,000

About The Position

The Senior Manufacturing Engineer will focus on initial development of our product in a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful equipment, fixture, and process design, as well as experience with line layout and station balancing activities. 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
5+ years of work experience
Demonstrated experience working with cross functional teams.
Generated and managed manufacturing documentation for a commercial medical device product (MPIs, LHRs, BOMs, TMs, 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

Nice To Haves

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

Responsibilities

Procure and install off the shelf manufacturing equipment and fixturing and perform qualification activities as required.
Define, design, document and/or specify manufacturing assembly fixtures and equipment and develop/perform IQ/OQ/PQ on equipment and fixtures.
Maintain equipment and fixtures on the line to prevent line down situations
Collaborate with product development and NPI team to fully understand the product, process, quality control plans, etc. and ensure the highest quality products are manufactured.
Author and maintain manufacturing documentation, including protocols, reports, manufacturing process instructions (MPIs), lot history records (LHRs), work instructions (WIs), test methods (TMs) and, if required component/product drawings.
Define and implement continuous process improvements to existing manufacturing operations including process verification, manufacturing documentation updates and process validation, etc. to improve scalability, product reliability, and cost structure.
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.
Support the assembly line for our design verification & validation and clinical launches.
Identify new potential vendors and suppliers and maintain relationships with existing vendors and suppliers.
Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure GMP.
Build the assembly line for our clinical launches.
Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic.
Lead quality system compliance including discrepant material dispositions, ECO implementation, and nonconforming evaluations.
Provide leadership and mentorship to team members as needed.
Other responsibilities to support sustaining manufacturing deliverables as needed.