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 for decades to come.

TITLE:  Senior NPI Process Development Engineer

POSITION SUMMARY:

The Senior 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
• Develop new processes to manufacture our products to meet device performance and cost targets.
• 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
• Specify, support and maintain the proper CER space to manufacture our medical devices under defined environmental quality controls.
• 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
• 4+ 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
• 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 with catheter or similar manufacturing (lamination, bonding, dip coating, ultrasonic welding, etc)
• 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 $140,000 and $175,000 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.

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 for decades to come.

TITLE: Product Development Manager, Mechanical Design

POSITION SUMMARY:

The Product Development 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, including career development and performance reviews
• Plan team staffing and recruitment to ensure project success
• Drive performance and technical requirement development
• Lead risk management activities
• Provide project management for device handles development, including defining milestones, cross-functional interdependencies, risks, and opportunities to expedite launch timelines
• Represent team in updates to senior management
• Work with NPI to develop processes and device assembly procedures
• Lead vendor selection activities for tooling, component, and subassembly sourcing
• 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
• 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
• 2+ years in technical leadership or management role
• Demonstrated experience working with cross functional teams
• Experience developing and launching high volume medical devices
• Capable with CAD modeling, engineering drawing generation, DFM, tolerance analysis and tooling design
• Experience creating and managing schedules, budgets, and plans.
• Solid understanding of design controls and risk management

PREFERRED QUALIFICATIONS:

• Experience managing engineers, technicians, or interns as direct reports
• Experience with disposables/consumables
• Experience with design and sourcing high volume injection molded components
• Developed products from invention to market release
• Experience in a start-up environment.
• Proficient with SolidWorks.

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 $180,000 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.

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 for decades to come.

TITLE: Manufacturing Engineering Technician (I/II/III), NPI

POSITION SUMMARY:

As an NPI Engineering Technician you will be responsible for supporting NPI Manufacturing Engineering in developing our Endoscopes from concept to product commercialization. They will support manufacturing prototypes, process development, equipment maintenance, and executing test protocols.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and 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:

• Collaborate with R&D and NPI engineers to evaluate and assemble new designs and manufacturing methods with the ability to work with little to no written instructions.
• Manufacture medical devices for prototype, process development, design verification, and commercialization phases.
• Assists engineering with defining manufacturing process instructions, and identifies critical equipment, fixtures, and tooling to aid in implementation of new designs
• Identify and investigate process, quality, and workmanship issues and assist engineering in documenting and implementing process improvements.
• Support engineers in executing test protocols to collect data to characterize manufacturing processes, Equipment Installation Qualifications (IQ), and Operational Qualifications (OQ), and Process Qualifications (PQ).
• Comfortable supporting manufacturing of multiple sub-assembly builds with the use of hand tools and equipment.
• Keep work area, equipment and materials clean, organized and properly identified.
• Conduct cross training with technicians and production assemblers and provide technical support as needed.

 QUALIFICATIONS:

• Experience with manufacturing processes such as coil winding, braiding, lamination, die bonding, hot box, adhesive dispensing, UV curing, and cutting techniques.
• Experience working directly with engineering during development and design transfer to refine process, equipment/tooling development, and inspection.
• Strong communication skills – ability to communicate in English orally and via writing.
• Positive demeanor with a strong work ethic and desire to be a big part of a growing organization.
• Minimum 5 years working in a medical device manufacturing industry preferably in catheter manufacturing.
• High school diploma or GED

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 hourly rate for this role is between $35 to $50 pr hour 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.