Senior Manufacturing Engineer

4 days ago

San Jose, California, United States BioRobotics Full time
Transforming Healthcare with PROCEPT BioRobotics

We are seeking a highly skilled Senior Manufacturing Engineer to join our team at PROCEPT BioRobotics. As a key member of our manufacturing team, you will play a critical role in driving quality, delivery, and cost improvements across the company.

About the Role

This is an exciting opportunity to bring your engineering expertise to a company that is revolutionizing treatment for benign prostatic hyperplasia (BPH). As a Senior Manufacturing Engineer, you will own critical internal and contract manufacturing processes, working closely with R&D and Process Development teams to transfer manufacturing processes into production and continuously enhance manufacturing capabilities.

Responsibilities
  • Take ownership of engineering support for both in-house and contract manufacturing floors, resolving production issues related to fixtures, tooling, and equipment with minimal supervision.
  • Lead root cause investigations related to manufacturing failures and technical challenges, driving resolution with cross-functional teams.
  • Identify and drive continuous improvement projects to enhance yield, consistency, and performance of equipment and processes.
  • Work with R&D and Process Development teams to transfer new products into commercial manufacturing, ensuring design for manufacturability (DFM/DFx).
  • Design, build, or procure complex fixtures, tooling, and equipment to improve quality, reliability, and yield.
  • Maintain controlled environments and ensure the cleanroom is safe, compliant, and suitable for manufacturing operations.
  • Write and execute test protocols and reports for complex new equipment or processes using statistically sound methodologies.
  • Conduct process capability assessments and establish process controls where required.
  • Lead process validation efforts, including process optimization studies, verifications, and validations for complex processes.
  • Provide engineering support and mentorship to junior engineers, operators, and technicians.
  • Train and provide work direction to manufacturing operators and technicians.
  • Travel up to 20% domestically and internationally.
Requirements
  • BS in Mechanical or Electrical Engineering with a minimum of five years of experience or an MS in Engineering with a minimum of three years of experience.
  • Experience in scaling up disposable manufacturing processes in a cleanroom environment, including welding and bonding technologies.
  • Experience in leading technical projects and supporting medical device manufacturing.
  • Strong root cause analysis and problem-solving skills.
  • Proficiency in Lean and Six Sigma methodologies, with experience in using statistical tools such as Minitab.
  • Knowledge of ISO9000, FDA QSR, and regulatory approval processes for medical devices.
  • Familiarity with welding standards, such as AWS C7.4, AWS C7.2M:2010, and ASTM A1069.
  • Basic working knowledge of CAD (SolidWorks or similar software).
  • Proficiency in Microsoft Office and SolidWorks.
What We Offer

We offer a comprehensive benefits package, including full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more.

About PROCEPT BioRobotics

At PROCEPT BioRobotics, we believe every person matters. Every employee, every patient, every caregiver. We are committed to creating a revolution in healthcare, and we believe in doing that by innovating everywhere with pathological optimism. We are fueled by the opportunity to give people their lives back, and we believe that it begins with YOU.

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