Senior Staff Manufacturing Engineer

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:            As we continue to grow and streamline our manufacturing operations, Procept BioRobotics is seeking a dedicated Principal Manufacturing Engineer. This role is crucial for bringing hands-on expertise, project management skills, and extensive knowledge of capital equipment to our team. You will take ownership of key internal and contract manufacturing processes, driving continuous improvement and leadership to enhance quality, delivery, and cost efficiency. Your journey at Procept will involve partnering with the R&D and Process Development teams to seamlessly transfer manufacturing processes into production.

What Your Day-To-Day Will Involve:

• Authority on process transfer and DFM/DFA activities; closely collaborate with design engineers, operations teams, and vendors. 
• Lead setup and transfer of internal or external vendor manufacturing assembly pilot lines and workstations. 
• Provide mentoring and technical leadership to junior engineers. 
• Conduct process Design of Experiments (DOEs) and perform process capability analysis. 
• Lead process and equipment validation activities, including protocol and report completion or approval. 
• Perform root cause investigations and implement corrective actions for assembly yield or field issues. 
• Lead or support continuous improvement and cost reduction projects. 
• Coordinate with suppliers and support supplier assessments and audits. 
• Provide engineering support to outside suppliers and contract manufacturers. 
• Train, develop, and/or provide work direction to operators and technicians. 
• May require up to 20% travel, domestic and international. 
• Maintain trained status for, and comply with, all relevant aspects of the Procept BioRobotics Quality Management System. 

The Qualifications We Need You to Possess

• BS in an Engineering discipline such as mechanical or mechanical engineering with a minimum of 12 years experience or an MS in Engineering with a minimum of 8 years experience. 
• Experience supporting medical device manufacturing or disposable and accessories manufacturing in a similarly regulated industry.  
• Subject Matter Expert on Manufacturing Mechanical Manufacturing Process such as Forming, Crimping, Stamping 
• Solid understanding of a wide range of standard and sophisticated manufacturing processes including understanding of key input variables for quality, cost, and capacity 
• Strong technical skills in Materials Science and Analysis, flexible instrument process development, IQ/OQ/PQs, PFMEA, and process control plans 
• Strong interpersonal and project management skills working with a wide variety of people, skills, and backgrounds 
• Experience with being audit-facing 
• Experience in leading highly technical projects in a cross functional environment both internally and with CMOs/Vendors. 
• Extensive experience with root cause analysis and problem solving for both technical and process issues. 
• Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements. 
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001and EN46001. 
• Working knowledge of CAD (Solidworks or other) software. 

The Qualifications We Would Like You to Possess

• Preferred experience with Lean and Six Sigma tools. 

Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for