Senior Process Engineer

Staff Process Engineer – Catheter Process & Equipment Development I’m working with a growing cardiovascular medical device company in Menlo Park that is hiring a Staff Process Engineer with strong catheter process development experience. The company has recently achieved an important U.S. regulatory milestone and is now moving into an exciting stage of manufacturing scale-up and commercialization! This is a particularly interesting opportunity for someone who enjoys the hands-on process and equipment side of engineering . Rather than simply maintaining an established manufacturing line, you’ll be helping develop and optimize custom manufacturing equipment and processes for a novel catheter-based technology. Job Focus: Catheter process development and optimization Development of custom manufacturing equipment Working directly with equipment builders, machine shops and outside vendors Fixture and tooling design (SolidWorks) DOE, process characterization and troubleshooting IQ/OQ/PQ and process validation Improving yield, repeatability and throughput Scaling processes and equipment into production Supporting the transition into commercial manufacturing The ideal candidate will have strong medical device process/manufacturing engineering experience, and enjoy being hands-on with equipment, fixtures, tooling and process development. This is a chance to join a well-funded, growing medical device company at a great stage — proven technology, an important regulatory milestone behind them, and plenty of interesting process and manufacturing development work still ahead. Local Candidates strongly preferred NO H1B VISA or Sponsorships - must have US Work Authorization or be a US Citizen #J-18808-Ljbffr Cambridge Recruiters