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Sr. R&D Engineer

2 months ago

Minneapolis, United States Silk Road Medical, Inc. 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 Sr. R&D Engineer is responsible for the design and development of new and improved products and procedures to address vascular diseases and conditions using minimally invasive techniques. This role leads design control activities for product development in a new therapeutic area from initial concept through commercialization. Products may include more complexity with a larger number of elements. 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"

  • Design, prototype and develop novel design solutions for catheter-based products to improve performance and ease of use in clinical procedures. Implements process change improvements. Provides guidance for the design and development of company products. Conceive and build working prototypes.
  • Plans and coordinates test builds, acts as technical lead for high-complexity projects, and conducts complaint and failure investigations.
  • Develop and lead verification and validation activities to ensure that product designs meet the customer needs. This shall include bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate.
  • Performs 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.
  • Maintain Design Control activities for new product development 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.
  • Represents ideas, acts as an idea champion, and sells ideas to the organization.
  • Works collaboratively with R&D, Marketing, Operations, Quality, Clinical and Regulatory and physician advisors to understand customer requirements and plays a key role in a cross-functional team to drive strategy and develop new products of high complexity to augment and enhance the company's existing product offerings.
  • Establish and maintain 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.
  • Work with Marketing and Medical Affairs to develop training tools and models; direct interface with field personnel and customers.
  • Support 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 in Biomedical Engineering, Mechanical Engineering, or a related discipline a plus.
  • Typically, 5+ years of R&D 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) is a plus.
  • Previous experience with implantable nitinol devices is a plus.
  • Extensive Product Development Process (PDP) experience for Medical Devices. Specifically, Design Control, Design Verification & Validation, Test Method Validation.

Additional skills you have

  • Strong computer skills in computer 3D modeling (SolidWorks), and FEA.
  • Proficient understanding and application of statistical techniques relevant to design verification. Analyzes and synthesizes data using statistical theory and software.
  • Recognized as a specialist in FDA Regulation and Quality systems requirements for Medical Device Manufacturers as applied to Product Design & Development and Design Controls; may mentor and coach earlier career engineers.
  • 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.
  • Strong and consistent ability to look beyond symptoms to identify the root cause of a problem. Synthesizes large amounts of complex information and data of diverse scope into a concise form to communicate recommendations/status to project leaders and/or key project stakeholders with very limited oversight.
  • 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.
  • Technical Leadership experience and strong report writing, drafting and documentation skills.
  • 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 www.srmbenefits.com.

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.