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Principal R&D Engineer

4 months ago

Brockton, Massachusetts, United States Silk Road Medical Full time

Who we are

Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California & Plymouth, MN, that is focused on reducing the risk of stroke and has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR).

We are always looking for dynamic and innovative individuals who are passionate about reducing the risk of stroke. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others with a strong emphasis on collaboration.

The opportunity

The Principal R&D Engineer will serve as an expert in the design and development of new products and procedures, utilizing innovative approaches that address vascular diseases and conditions using minimally invasive techniques. This role will lead design control activities for highly complex product development in new therapeutic areas from initial concept through commercialization. These activities may include the following: developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.

This is a hybrid position.

A "Day in the life"

  • Leads the design, prototype, and development of new therapeutic areas with increased complexity, scope, and multiple components to improve performance and ease of use in clinical procedures. Implements process change improvements.
  • Plans and facilitates test builds, acts as technical lead for high-complexity projects, and conducts complaint and failure investigations. Leads collaborative efforts in the design and development of test methods and associated test fixtures to be used in the test and evaluation of new products.
  • Develops and leads verification andvalidation activities to ensure that product designs meet customer needs. This includes bench testing, model/fixture development,ex vivoand/orin vivotesting as appropriate.
  • Performs highly complex troubleshooting associated with product/process problems as related to design, material, or process.Makes meaningful recommendations based on the findings and analysis of data. Aids in the prevention of program delays.
  • Maintains Design Control activities for new product development from initial concept through commercialization.
    Represents ideas, acts as an idea champion, and sells ideas to the organization.
  • Creates collaborative relationships within R&D and with cross functional partners such as Marketing, Operations, Quality, Clinical, Regulatory, and physician advisors to understand customer requirements and takes initiative to drive strategy and develop new products of high complexity to augment and enhance the company's existing product offerings.
  • In partnership with a cross functional team, acts as a co-lead of the development for field training support. Serves as technical lead in the development of department or division procedures with respect to training support.
  • Provides mentorship to team members while simultaneously working independently to plan, schedule and execute activities necessary to meet project timelines. Acts as a guide in project planning, budgeting, scheduling, and tracking. May create and pursue goals for the department that have a positive impact on business performance.
  • Develops, maintains and leads partnerships with OEM suppliers, development partners, and other vendors as projects require.
  • Leads by example, emulates work values. Represents a strong team culture through high expectations & high performance.
  • Supports the development and upkeep of the Company's Quality System in conjunction with the Company's Quality Department.

What you'll bring

  • BS in Biomedical Engineering, Mechanical Engineering, or a related discipline. MS preferred.
  • 8+ years of R&D Engineering experience in the Medical Device Industry.
  • Previous hands-on bench skills & prototyping experience.
  • Previous experience with catheter design and manufacturing (i.e. coil winding, braiders, shaft design, handle design) preferred.
  • Previous experience with implantable nitinol devices preferred.
  • Extensive Product Development Process (PDP) experience for Medical Devices. Specifically, Design Control, Design Verification & Validation, Test Method Validation.
  • Technical Leadership experience and strong report writing, drafting and documentation skills.
  • Ability to travel up to 10%.

Additional skills you have

  • Advanced computer skills in computer 3D modeling (SolidWorks), and FEA.
  • High level understanding and application of statistical techniques relevant to design verification.
  • Ability to analyze and synthesize data using statistical theory and software.
  • Recognized as a subject matter expert in FDA Regulation and Quality systems requirements for Medical Device Manufacturers as applied to Product Design & Development and Design Controls.
  • Strong ability to work independently to plan, schedule and execute activities necessary to meet project timelines.
  • Participates in project planning, budgeting, scheduling, and tracking.
  • Takes initiative in acting upon shared ideas.
  • Intricate and detailed ability to look beyond symptoms to identify the root cause of a problem. Synthesizes and analyzes information from a wide variety of sources and perspectives to arrive at a broad, deep, and well-integrated understanding of the problem. Develops multiple solutions to address issues at hand. Utilizes experience and perspective to identify new potential failure modes.
  • Excellent hands-on design and prototyping skills.
  • Highly organized, energetic, self-starter who exhibits strong communication skills with cross-functional team members, project leads, and physician advisors.
  • Regularly moving about to accomplish tasks or moving from one workstation to another.
  • Occasionally, adjusting or moving objects up to 25 pounds in all directions.
  • Occasionally, repeating motions that may include the wrists, hands, and/or fingers.
  • Sedentary work that primarily involves sitting/standing.

Come join our team where we celebrate diversity and embrace everyone's unique talents We encourage individuals from all backgrounds to apply.

What we offer

Our philosophy is to make all benefits affordable to all Silk Road Medical employees and their dependents. We offer robust and affordable benefits with modest employee contributions. Click here for more information

Our Commitment to Diversity, Equity & Inclusion

We welcome all people who want to be part of our amazing journey and mission to provide new, innovative, and clinically proven transcarotid therapies to prevent the devastating burden of stroke. Our employees come from very different backgrounds: different races and ethnic backgrounds, different religions, and different parts of the world. Some of us are married to people of the opposite sex and some to the same sex, some are not married. Some of us are becoming parents for the first time and others are counting down the days to retirement. Some of us do cartwheels every day and some need physical accommodation to best perform their role. All are welcome.

We have a diverse workforce because we believe that it is possible for people with different backgrounds, viewpoints and persuasions to come together and debate important topics, learn from one another, and make better decisions than we would if we all were all the same. We want Silk Road Medical to not only be a great place to work, but The Greatest Place to Work and we strongly believe that a diverse and inclusive working environment is critically important to that goal.

Silk Road Medical is an equal opportunity employer and we value diversity at our company. We strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.