R&D Manager, Mechanical Design

Posted 5 Days Ago
Be an Early Applicant
Burlingame, CA, USA
In-Office
180K-231K Annually
Senior level
Healthtech
The Role
Manage a mechanical engineering team developing drive mechanisms and robotic equipment interfaces for a novel medical endoscopy platform. Responsibilities include technical leadership, staffing, risk management, project planning, vendor selection, manufacturing process improvement, DFM, quality compliance, and medical device launch activities under FDA QSR and ISO 13485 requirements.
Summary Generated by Built In

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 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.

Skills Required

  • Bachelor’s or master’s degree in mechanical engineering or a related engineering discipline
  • 8 or more years of professional work experience
  • 2 or more years in a technical leadership or management role
  • Experience working with cross-functional teams
  • Experience developing and launching high-volume medical devices
  • Proficiency with CAD modeling, engineering drawing generation, design for manufacturability, tolerance analysis, and tooling design
  • Experience creating and managing schedules, budgets, and plans
  • Strong understanding of design controls and risk management
  • Experience managing engineers, technicians, or interns as direct reports
  • Experience with disposables or consumables
  • Experience designing and sourcing high-volume injection-molded components
  • Experience developing products from invention through market release
  • Experience in a startup environment
  • Proficiency with SolidWorks
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The Company
HQ: Burlingame, California
111 Employees
Year Founded: 2016

What We Do

Neptune Medical is a venture capital funded medical device start-up, located in the Silicon Valley town of Burlingame. We develop, manufacture, and commercialize high-volume, high clinical utility medical devices initially commercialized for gastroenterology, see our website below. Our patent-pending technology is foundational and will have a broad impact across multiple additional clinical areas, including including GI, cardiovascular, pulmonary, and neuro. Our Triton Medical Robotics division is developing flexible robotic systems that address enormous unmet needs across multiple major medical indications. Our products incorporate unique Dynamic Rigidization™ technology that instantly toggles thin-walled tubes- such as overtubes, catheters or cannulae - between flexible and rigid states. This novel technology creates unprecedented opportunities for significantly enhanced access and control deep within the body. Neptune Medical currently has ~50 full time employees across all divisions, including a core team of serially successful medical device entrepreneurs. The company has raised over $30M in capital from a diversified investor base, including venture capital, private equity, and industry insider and clinician angel investors.

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