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Principal Packaging Engineer

Silk Road Medical
May 16, 2024

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 Packaging Engineer will serve as the expert in the design, development, and testing for new and existing products in relation to packaging, labeling and sterile barrier solutions for innovative medical device products. This role will lead design control activities for product development in new and existing therapeutic areas from conception to commercialization. These activities may include the following: developing product packing specifications, design evaluation, risk analyses and setting and executing design verification and validation strategies. This role will collaborate with cross-functional teams as the packaging expert to support the launches of new devices and support existing commercial lines.

This is a hybrid position.

A "Day in the life"

  • Lead the design and development of new packaging systems for innovative new medical devices.
  • Provide strong technical leadership within a cross-functional team to drive the design and development of innovative new products or optimization of existing packages.
  • Provide guidance and expertise in the support of existing commercial products for packaging and labeling design and process improvements.
  • Understand and develop packaging customer and business requirements.
  • Craft packaging solutions engineered to safeguard and extend the longevity of products throughout their lifecycle, protecting and preserving products during transportation, storage, and handling.
  • Conduct comprehensive feasibility studies to determine the suitability of packaging solutions for specific products.
  • Drive and implement improvements within the packaging landscape through in-depth data analysis and research.
  • Maintain and execute standard operating procedures and guidelines for product packaging in the company.
  • Ensure consistency and quality of packaging across the organization, maintaining a commitment to excellence.
  • Oversee the strategic development and upkeep of labeling design, process, and equipment.

What you'll bring

  • BS in Engineering or a related discipline. Masters preferred.
  • 8+ years packaging engineering experience preferably in the Medical Device Industry.
  • Experience in developing packaging within the Product Development Process (PDP) for Medical Devices.
  • Ability to travel up to 10%.

Additional skills you have

  • Previous experience with design of sterile packaging systems.
  • Experience in developing and support packaging systems for Medical Devices. Specifically, Design Control, Design Verification & Validation, and process development.
  • Working knowledge of packaging materials and packaging component production; sterile pouches, thermoforming, carton forming, and product labeling solutions.
  • Possess strong working knowledge of UN/DOT, EPA, and FDA standards and requirements.
  • Have experience in Design for Manufacturing, FMEA, DOE, and Process Validations.
  • Experience in managing packaging suppliers.
  • Highly organized, energetic, self-starter who exhibits strong communication skills with cross-functional team members.
  • Demonstrate initiative and ability to work independently, handle multiple tasks and projects simultaneously.
  • 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 https://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.

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