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Senior Manufacturing Engineer
1 month ago
Embark on a rewarding journey with PROCEPT BioRobotics, where innovation and passion drive our mission to revolutionize treatment for benign prostatic hyperplasia (BPH). As a Senior Manufacturing Engineer, you will play a critical role in scaling up disposable manufacturing processes in a cleanroom environment, leveraging your expertise in welding and bonding technologies.
The OpportunityAs a key member of our team, you will own critical internal and contract manufacturing processes, driving quality, delivery, and cost improvements across the company. You will work 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).
- 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.
We are seeking a highly skilled and experienced Senior Manufacturing Engineer with a strong background in mechanical or electrical engineering. The ideal candidate will have:
- 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, and ASTM A1069.
- Basic working knowledge of CAD (SolidWorks or similar software).
- Proficiency in Microsoft Office and SolidWorks.
As a Senior Manufacturing Engineer at PROCEPT BioRobotics, you will be part of a dynamic team that is passionate about transforming healthcare. We offer a comprehensive benefits package, including full medical coverage, wellness programs, on-site gym, 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.
We are an equal opportunity employer 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.
Join us in our mission to revolutionize treatment for BPH and make a difference in the lives of patients and healthcare providers.
