Senior Manager
QA Sustaining, Disposable & Accessories
Confirmed live in the last 24 hours
PROCEPT BioRobotics

501-1,000 employees

Surgical robotics for minimally-invasive urologic procedures
Company Overview
PROCEPT BioRobotics is a pioneering surgical robotics company that excels in the urology field, offering the AQUABEAM Robotic System, a state-of-the-art, image-guided surgical robotic system for minimally-invasive urologic surgery. The company's proprietary Aquablation therapy, delivered by the AQUABEAM system, merges real-time, multidimensional imaging, personalized treatment planning, automated robotics, and heat-free waterjet ablation, enabling precise and rapid removal of prostate tissue. This approach ensures effective, safe, and durable outcomes for patients with lower urinary tract symptoms due to BPH, irrespective of prostate size, shape, or surgeon experience, marking a significant shift in the surgical treatment of BPH.
Robotics & Automation
B2B

Company Stage

N/A

Total Funding

$679.7M

Founded

2009

Headquarters

San Jose, California

Growth & Insights
Headcount

6 month growth

21%

1 year growth

48%

2 year growth

163%
Locations
San Jose, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Quality Assurance (QA)
CategoriesNew
QA & Testing
Requirements
  • BS in Mechanical Engineering or Quality or a similar engineering discipline
  • 10+ years of progressive experience in medical device quality engineering (NPI, Sustaining)
  • 5+ years of direct technical supervisory experience
  • Familiarity with U.S. FDA GMP requirements for manufacturers
  • Demonstrated reasoning ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
  • Excellent interpersonal and communication skills across all levels of the organization
  • Ability to work in a dynamic, fast-paced environment with strong ability to establish technical and professional credibility
  • Ability to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas
Responsibilities
  • Oversee the Quality Engineering team by developing and implementing in-depth strategies and project plans to improve product quality
  • Create, apply, and monitor performance metrics for personnel, products, and processes
  • Identify and implement appropriate Key Performance Indicators, KPIs to monitor and improve process and product performance
  • Collaborate with Manufacturing Engineering team to improve production processes
  • Implement a robust process validation, including improvement to Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ)
  • Lead improvement in the collection and analysis of data
  • Lead improvements to the statistical process control (SPC) process by implementing process throughout the manufacturing and inspection processes
  • Lead continuous improvement projects to improve product quality and reliability and to reduce cost of goods sold
  • Lead updates to (PFMEA) for all current and future devices
  • Identify and implement projects that include reliability improvements, product manufacturability and cost reductions
  • Lead in-depth product and process failure investigations to determine root causes of failures and to implement effective and preventive actions
  • Manage the tactical and operational execution of short and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing
  • Work with cross functional teams on issues of diverse scope, where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends
  • Interact with production management to help determine production capacities, define workspace requirements, workflow, and layout of equipment for optimal efficiency
  • Plan annual budget to ensure resources are adequate to execute approved projects and goals
  • Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce
  • Drive projects through cross functional collaboration, timeline, and schedule management
  • Prepare and issue timely status updates on active projects for review by Senior Management
  • Assure compliance to all company policies, standard operating procedures and recognized domestic/international standards
  • 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 & EHS Policies
Desired Qualifications
  • Advanced degree in Mechanical Engineering or Quality or a similar engineering discipline