R&D Manager, Mechanical Design
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: 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.