Staff Manufacturing Engineer

Company: PROCEPT BioRobotics
Location: Redwood City
Posted on: February 19, 2021

Job Description:

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company's AquaBeam-- Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience.

Summary

As we continue to grow and streamline our manufacturing operations, PROCEPT now needs to hire a Staff Manufacturing Engineer who can bring their hands-on and project management expertise as well as their extensive capital equipment know-how to the company. The new Engineer will take ownership of key internal and contract manufacturing processes. The new hire will bring strong continuous improvement and leadership competencies to drive quality, delivery, and cost improvements in manufacturing and this will include reviews of current capabilities and establishing new processes.
She/He will also partner with the R&D and Process Development teams to transfer manufacturing processes into production.

CORE RESPONSIBILITIES (Other Duties May Be Required As Assigned)

• Lead engineering support to manufacturing and resolve issues impacting production fulfillment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment).
• Champion continuous improvement by identifying projects to create and support best in class lean manufacturing systems to maximize yield, capacity, and capability.
• Identify, justify and implement multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
• Develop and enable data driven operational and financial decisions through predictive insights into tool and process performance.
• Generate and execute business improvement ideas for cost reduction, labor savings, material flow and safety.
• Design and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards.
• Identify and recommend manufacturing technologies to strategically develop business objectives and potential opportunities.
• Responsible for process documentation and ensuring it is kept current like Manufacturing Instructions, Standard works documents, PFMEA, standard works and Control Plans.
• Work with R&D and Process Development teams to transfer new products into commercial manufacturing, both in-house and at contract manufacturer.
• Identify, define and execute new technical projects that improve manufacturing processes - this will include developing the scale, scope and ROI.
• Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield.
• Provide floor layouts for areas associated with manufacturing operations.
• Write test protocols, preform tests to fully characterize new equipment or processes utilizing DOE methodology or other statistically sound methods, then write completion reports.
• Perform process capability assessments and establish methods to control process output.
• Create process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports.
• Write and perform IQ's, OQ's and PQ's when introducing new or changing existing manufacturing equipment.
• Provide engineering support to outside suppliers and contract manufacturers, ensuring quality and production targets are met.
• 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 to ensure product and support regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics Quality Policy.
• Understand and adhere to the PROCEPT BioRobotics EHS Policy.
  
  QUALIFICATIONS (Education, Experience, Certifications)
  
  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  • BS in an Engineering discipline such as mechanical or electrical engineering with a minimum of 8 years' experience or an MS in Engineering with a minimum of 6 years' experience.
  • Experience supporting medical device manufacturing.
  • 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.
  • Preferred experience with Lean and Six Sigma tools.
  • 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 ISO13 or ISO9001and EN46001.
  • Basic working knowledge of CAD (Solidworks or other) software.
  • Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.
    
    Supervisory Responsibilities
    
    May include the technical supervision of Manufacturing Engineer(s) and/or Manufacturing Engineering Technician(s).

Keywords: PROCEPT BioRobotics, Redwood City , Staff Manufacturing Engineer, Engineering , Redwood City, California