Senior Manufacturing Engineer, Endoscopy jobs in United States
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Neptune Medical · 16 hours ago

Senior Manufacturing Engineer, Endoscopy

Neptune Medical is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. The Senior Manufacturing Engineer will focus on initial development of their product in a manufacturing setting, engaging in cross-functional collaboration to accelerate product development and implement manufacturing improvements.

Health CareMedicalMedical DeviceRobotics
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H1B Sponsor Likelynote

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

Qualification

Manufacturing documentationProcess validationCAD modelingGMP knowledgeDFM expertiseCross-functional collaborationLeadershipTeamworkCommunicationProblem-solving

Required

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

Preferred

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

Benefits

Equity
Benefits
401(K) with matching

Company

Neptune Medical

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Neptune Medical is a medical device company that develops endoscopic and surgical devices.

H1B Sponsorship

Neptune Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (9)
2023 (1)
2022 (2)

Funding

Current Stage
Late Stage
Total Funding
$97M
2024-08-15Series D· $97M
2020-05-26Series Unknown
2019-01-01Series Unknown

Leadership Team

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Alex Tilson
Founder & CEO
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Company data provided by crunchbase