Senior/Principal R&D Project Engineer

TITLE:  Senior/Principal R&D Project Engineer

SUMMARY:

Neptune Medical (NM) is a venture-backed medical device company based in Silicon Valley. We are the creator of the proprietary Dynamic Rigidization™ technology, which is used to instantly transition devices  between flexible and rigid states. We have commercialized our first devices for the diagnosis and treatment of multiple endoscopic procedures. We are seeking a great candidate to join the GI team to help 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. 

The ideal candidate would provide leadership and project management to cross-functional teams, would update existing devices, and would develop new devices according to all pertinent medical device regulations optimizing 'time to market', while developing and managing timelines within division goals.

The candidate is responsible for the implementation of continuous product and process improvement measures including ongoing document updates of commercial devices as well as comprehensive product development of next generation medical devices. The candidate coordinates and supports design and development, V&V activities, and integration of all design control documentation necessary to support regulatory submissions, design transfer to manufacturing and maintenance of Design History Files throughout the product lifecycle.  Importantly, the candidate will manage & mentor junior engineers and/or co-ops.

JOB DUTIES AND RESPONSIBILITIES:

• Lead cross-functional teams to execute design and development projects and related activities to meet division schedules according to applicable medical device regulations.
• Monitor and manage project timelines (including R&D builds) and resourcing to anticipate issues and to prevent project timeline delays.
• Support the R&D team to develop impactful short and long-term strategies and action plans to drive product development to achieve the required results.
• Generate Projects Plans, Design and Development Plans.
• Support the R&D team to prepare conceptual ideas (sketches, and design concepts) to convert them into medical device design inputs requirements, design criteria, device features and benefits.
• Develop test methods and protocols for new or existing product designs.
• Manage and participate in design verification and validation to confirm the design outputs meets the design requirement parameters.
• Lead continuous improvement projects such as design changes for materials, components, finished products, processes and related procedures.
• Collaborate with QA for risk management, plans, analysis, and related activities per ISO 14971.
• Support QA with development studies such as biocompatibility, extractables and leachable testing per ISO 10993.
• Provide broad engineering knowledge to the design and development of new or existing product changes and enhancements.
• Build strong team relationships to enable the execution of project and solutions to problems.
• Collaborate with QA and RA to ensure the design and manufacturing process complies with ISO 13485, FDA 21 CFR 820 and applicable international regulations and standards such as EU MDR.
• Provide work direction to co-ops and/or junior engineers
• Manage third party vendors to ensure that the vendor deliverables are meeting the product and timeline requirements

ESSENTIAL REQUIREMENTS:

• B.S. or M.S. in Mechanical Engineering or Biomedical Engineering.
• A minimum of 8 years’ experience in Medical Device R&D with increasing responsibility and demonstrated ability in leading teams.
• Great understanding of all elements (design and design controls) required to take a product from feasibility to launch.
• Lead the creation of schedules, parallel paths, and broader team goals.
• Draw conclusions and make recommendations based on technical inputs from multiple and varied sources, combined with a good understanding of the relevant technologies.
• 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.
• Take initiative and act quickly to drive solutions.
• Technical writing skills, documentation, and proficient in general computer skills including Word, Excel, PowerPoint, and email communication.
• Must have strong verbal and written communication skills and the ability to communicate effectively across all levels of the organization.
• Lead and present project design reviews.
• Experience with managing junior engineers and/or co-ops
• Ability to travel domestically and internationally

HIGHLY DESIRABLE SKILLS:

• Developed products from invention to market release.
• 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.
• Strong clinical background with a thorough knowledge of anatomy and disease, exposure to doctors, and surgical procedure development.
• Strong experience with medical device quality systems, V&V studies, and regulatory filings (510k and EU MDR).
• Proficient with SolidWorks.
• PMP certification.

PLEASE SEND US:

• Your resume.
• A short cover letter showing us that you have read this and are responding to our needs. This really matters! Tell us, briefly, why you could be great in this role.
• Some samples of your work. This could be a link to a website, a portfolio in PDF or word, some JPGs, or whatever you think can give us a sense for what you have done.
• Applying through LinkedIn in preferred, but can also send to [email protected]
• We are located in Burlingame, CA near the Millbrae BART and Caltrain stations.

Compensation: our job titles may span more than one career level. The starting base pay for this role is between $160,000-$200,000. The actual base pay is dependent upon many factors, such as: 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 bonus, equity, and benefits.

Neptune Medical is an Equal Employment Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, marital status, national origin, protected veteran status, disability, or any other legally protected class.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please contact us at [email protected]