Product Development Engineer II

3 days ago

Burlingame, United States Neptune Medical Full time
TITLE: Product Development Engineer II

SUMMARY:

Neptune Medical (NM) is a venture-backed medical device company based in Silicon Valley. We are the developer of the proprietary Dynamic Rigidization™ technology that instantly toggles thin-walled tubes such as overtubes and catheters between flexible and rigid states. We have commercialized our first overtubes for the diagnosis and treatment via a variety of endoscopic procedures. We are seeking a compelling candidate to join the GI product team who can develop products and processes that significantly advance NM's clinical and market success. The ideal candidate would display the ability to perform the below requirements, would show a high level of individual responsibility, and would act with passion and intensity in a VC-funded medical device start-up that is fast-paced and collaborative.

JOB DUTIES AND RESPONSIBILITIES:
  • Supports project leader and works cooperatively with quality, manufacturing, regulatory, and marketing on complex projects to ensure project success
  • Utilize clinical knowledge to develop bench and tissue models
  • Write plans, protocols, conduct formal testing, and report results of preclinical, formative, summative, and validation studies throughout the design process
  • Help generate innovative and unique solutions to market needs and submit idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment
  • Prepares standard reports/documentation to communicate results to team
  • Summarizes, analyzes, and draws conclusions from test results.
  • Designs and coordinates standard engineering tests and experiments
  • Responsible for engineering documentation
  • May manage, train, and/or provide work direction to Tech, Assembler, Co-op, or Intern as a direct report
  • Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success
  • Demonstrates Product Life Cycle system knowledge through delivery of high-quality deliverables
Required Qualifications:
  • B.S. or M.S. in Mechanical Engineering or Biomedical Engineering, or related engineering bachelor's or higher degree
  • 2+ years of experience in a product development role as a hands-on product development engineer, medical device experience preferred
  • Experience collaborating with physicians and collecting feedback on clinical use of the product
  • Participated in and successfully contributed to multiple projects in multiple phases of the development cycle
  • Works independently to plan and schedule own activities necessary to meet timelines
  • Good understanding of all elements (design and design controls) required to take a product from feasibility to launch
  • Good mechanical engineering skills, specifically with catheters, machined and injection molded components, design for manufacturability and planning
  • Designed, procured, and fabricated tooling and fixtures
  • Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
  • Good organizational, communication and collaboration skills
  • Takes initiative and acts quickly to drive solutions
  • Contributes to IP Generation
  • A willingness to work hard with a driven outlook and with a strong desire to succeed as an engineer, as a team player, and as a company
Preferred Qualifications:
  • Developed products from invention to market release. Give us some examples
  • Experience in a start-up environment wearing multiple hats.
  • Experience with medical device manufacturing.
  • Strong mechanical engineering skills, including with catheters, machined and injection molded components, design for manufacturability, and planning
  • Good clinical background with a thorough knowledge of anatomy and disease, exposure to doctors, and surgical procedure development. Do your current professional contacts include MDs?
  • Experience with medical device quality systems, V&V studies, and regulatory filings (510k and EU MDR)
  • Experience with industrial design and product design. Have you worked on issues such as usability, need finding, and product appearance?
  • Experience with SolidWorks
  • Particular expertise in the area of materials, including polymers, is desirable.
  • Made contributions to an IP portfolio. Can you cite any pending or issued patents?

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 $100,000 and $140,000 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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