Senior Manufacturing Engineer

4 weeks ago

San Jose, California, United States PROCEPT BioRobotics Full time
Job Description

At PROCEPT BioRobotics, we are seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our manufacturing organization, you will be responsible for owning critical internal and contract manufacturing processes.

Key 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.

Preferred Qualifications:

  • Experience supporting electromechanical medical device manufacturing in a regulated industry.
  • Experience in leading technical projects in a cross-functional environment, both internally and with external manufacturers.

Benefits:

PROCEPT BioRobotics offers 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.

Equal Employment Opportunity Statement:

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws.

Pay Range Transparency:

Procept is committed to fair and equitable compensation practices. The pay range for this role is $120,000 - $160,000 per year, plus bonus.

Work Environment:

We will provide you with training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.

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