R&D Engineer II

4 weeks 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 R&D II Engineer is responsible for the design and development of new products to address vascular diseases and conditions using minimally invasive techniques.

This is a hybrid position.

A "Day in the life"

  • Design, prototype, develop, and evaluate catheter design and device solutions to improve performance, reliability, and ease of use in clinical procedures.
  • Perform Design Control activities for new product development from initial concept through commercialization. Including developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.
  • Perform design verification & validation activities to ensure that product designs meet the customer needs of post-market changes. This shall include bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate.
  • Perform troubleshooting of issues related to new products as related to design, material, or process.
  • Work with physician customers to define and validate customer requirements.
  • Develop product performance specifications and development of new test methods for design verification, characterization and optimization.
  • Work with external suppliers to specify new component and subassembly specification and complete qualification.
  • Work collaboratively with other functions including Marketing, Operations, Quality, Clinical and Regulatory to ensure product success.
  • 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.
  • 2 + years of R&D experience in the Medical Device Industry. Previous hands-on bench skills & prototyping experience.
  • Be willing to travel up to 10%.

Additional skills you have

  • Computer Skills: Computer 3D Modeling (SolidWorks), FEA desirable (not required), Microsoft Office Suite.
  • Understanding of FDA Regulations and Quality Systems requirements for Medical Device Manufacturers.
  • Excellent oral and written communication skills.
  • Ability to work well within a cross-functional team environment.
  • Highly organized, energetic, self-starter.
  • Flexible with respect to work assignments, which will include (but not limited by): Engineering Design, Hands-on Prototyping, Bench Testing, Documentation, and Field Training, and direct customer interaction.

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.


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