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Sr. Process Development Engineer

2 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 Sr. Process Development Engineer is a core cross-functional member of NPD (New Product Development) teams. Responsibilities include ownership of developing the manufacturing process, leading PFMEA, and manufacturing pilot/qualification builds as well as contributing to product design specifications, DVT, and other development team activities.

This is an onsite position.

A "Day in the life"

New Product Development (80%)

  • Serves as operations liaison on NPD teams (manufacturing, supply chain, supplier component engineering, and manufacturing engineering).
  • Contributes cross-functionally to product design to ensure design for manufacturability.
  • Leads process characterization and development activities (screening experiments, DOE, process mapping for inputs/outputs, equipment design and selection).
  • Leads design of process tooling, fixtures, and equipment. This may involve varying degrees of semi-automation.
  • Creates manufacturing documentation (SOP's and records).
  • Leads PFMEA activities and contributes to other aspects of risk management.
  • Leads job safety risk assessments for new processes and equipment designs.
  • Leads manufacturing pilot builds and IQ, OQ, PQ.
  • Ensures all manufacturing processes are developed with the operator in-mind (ergonomics, safety), Lean methodologies, waste reduction, one-piece flow, and Cycle Time / TAKT Time.
  • Serves as the liaison for projects involving outsourcing/contract manufacturing.

Sustaining Engineering (20%)

  • Supports manufacturing and sustaining engineering team members as needed to eliminate waste, improve yields and improve operator safety.
  • Designs and qualifies equipment/fixture that improves/streamlines manufacturing processes.
  • Performs investigation and material disposition for Non-Conforming Material Reports (NCMRs).
  • Performs root cause investigations and develop Corrective Action and Preventative Action (CAPA) plans.
  • Responds to manufacturing emergencies and resolve Production line down(s).
  • Leads and coordinates activities of technicians in support of equipment/process development, equipment/process troubleshooting, and custom equipment procurement.
  • Contributes to developing partnerships with new suppliers. Performs supplier qualifications for 2nd sourcing of components (may involve component design changes).

What you'll bring

  • Bachelor's degree required. BS in Engineering strongly preferred.
  • 5+ years of manufacturing engineering experience with process design, development, and deployment on product development teams.
  • Prior experience directly supporting medical device manufacturing (troubleshooting, safety improvements, operator training, process control plans, NCMR disposition, etc.)
  • Prior experience with catheter, stent, or balloon manufacturing and process development: reflow, braid/coil transfer, tipping (glass, RF, laser), laser bonding (balloon, joints), marker band, nitinol processing (laser cutting, polishing, etc.), crimping, & lubricious coating strongly preferred.
  • Prior experience in medical device or regulated industry required.

Additional skills you have

  • Ability to solve complex problems and deal with a variety of variables in pressure situations.
  • Excellent verbal and written communication skills.
  • Excellent attention to detail, flexible, and adaptable to change.
  • Excellent analytical and mathematical skills including statistics.
  • Experience using problem-solving methodologies (DMAIC, PDCA) with tools (process map, thought map, fish bone, cause/effect, DOE) with a variety of variables to solve and eliminate problems.
  • Experience working with semi-automation (mechanical, actuators, stepper motor, HMI, PLC's) either directly or outsourced.
  • Must be self-motivated, highly organized, and resourceful in solving manufacturing issues.
  • Possesses a well-developed team orientation with advanced critical thinking and problem-solving/analytical skills.
  • Requires working knowledge in DFM, Lean Six Sigma methodologies, as well as DOE and Statistical Process Control.
  • Ability to design fixtures and components in SolidWorks (CAD).
  • Occasionally, adjusting or moving objects up to 50 lbs.
  • Occasionally, repeating motions that may include the wrists, hands, and/or fingers.
  • Requires occasional travel.

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.