About this opportunity
Neptune Medical lists this R&D Manager, Mechanical Design opportunity in burlingame, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes fordecades to come.
Title
R&D Manager, Mechanical Design
Position Summary
The R&D Manager, Mechanical Design will manage a group of engineers developing the drive mechanism and interface to robotic capital equipment for a novel robotic endoscopy system.
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
Manage 5-7 direct reports
Work with product development to design and prototype novel manufacturing processes and equipment
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
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.
Required Qualifications
B.S. or M.S. in Mechanical or Related Engineering
8+ 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
Experience with process development for catheters, balloon catheters, guidewires, or similar medical devices
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.
Preferred Qualifications
Experience managing engineers, technicians, or interns
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
Neptune Medical 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 $170,000 and $231,000 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.
Neptune Medical 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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Worksite address
burlingame, CA, 94012, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.