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Sr. Process Development Engineer, Catheter Engineering

pulsebiosciences · Hayward, CA - Onsite · Hayward, California, United States
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<div class="content-intro"><p><strong>Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine</strong></p> <p>Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.  The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.</p> <p>The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit <a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fpulsebiosciences.com%2F&esheet=53299490&newsitemid=20230202005390&lan=en-US&anchor=pulsebiosciences.com&index=2&md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.</p> <p><strong>Why Join Us?</strong></p> <p>At Pulse Biosciences, we are driven by purpose and innovation.</p> <ul> <li><strong>Our Mission:</strong> To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.  We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. </li> <li><strong>Our Culture:</strong> A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li> <li><strong>Our Commitment:</strong> Hiring the best and brightest minds to advance our world-class organization.</li> </ul> <p><strong>What You Will Experience:  </strong></p> <ul> <li><strong>Culture and Purpose </strong>- Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li> <li><strong>Innovative Environment </strong>- An environment that fosters innovation to take products from concept to human use <em>quickly!</em></li> <li><strong>Growth Opportunities</strong> - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li> <li><strong>Comprehensive Benefits</strong> - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li> <li><strong>Ownership and Rewards </strong>- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li> <li><strong>Work-Life Balance - </strong>Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li> <li><strong>Diversity & Inclusion</strong> - A commitment to providing a respectful work environment to our diverse workforce. </li> </ul></div><p><strong>About the Role</strong></p> <p>The Sr. Process Development Engineer will be responsible to bridge early-stage device development and commercial-grade manufacturing. This individual will take first-in-human catheter devices and refine them into robust, manufacturable products ready for commercial launch. The ideal candidate will bring deep catheter engineering expertise, a manufacturing mindset, and a proven track record of successful medical device design transfer.</p> <p><strong>To Make an Impact, You Will:</strong></p> <ul> <li>Lead process development activities to transition early-stage catheter devices from first-in-human configurations to commercially viable, scalable products.</li> <li>Perform DFM/DFA analyses and tolerance stack-up studies (worst-case and statistical) to eliminate producibility risks, define critical dimensions, and establish component acceptance criteria.</li> <li>Develop and maintain detailed component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans, in alignment with device performance requirements and supplier capabilities.</li> <li>Characterize and optimize catheter manufacturing processes including extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting to achieve robust, repeatable outcomes.</li> <li>Develop and optimize electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface mount component placement, and high- and low-voltage cable assembly fabrication in compliance with applicable industry workmanship standards.</li> <li>Partner with Manufacturing Engineering on process validation (IQ, OQ, PQ) and process FMEAs; contribute to protocols, risk documentation, and control definitions to ensure regulatory compliance.</li> <li>Collaborate with Manufacturing Engineering to establish SPC methods, capability studies (Cp, Cpk), yield targets, and build monitoring frameworks that support production stability and COGS objectives.</li> <li>Develop inspection gauges and conduct MSA/gauge R&R studies to validate measurement system capability.</li> <li>Evaluate and qualify raw materials, adhesives, and components; a

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