Compensation Overview

CORE 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.
• Closely 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)
• Leads improvement in the collection and analysis of data.
• Leads improvements to the statistical process control (SPC) process by implementing process throughout the manufacturing and inspection processes. 
• Leads continuous improvement projects to improve product quality and reliability and to reduce cost of goods sold.
• Leads updates to (PFMEA) for all current and future devices.  
• Identify and implement projects that include, but are not limited to, 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.

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 Mechanical Engineering or Quality or a similar engineering discipline required but advanced degree desirable.
• 10+ years of progressive experience in medical device quality engineering (NPI, Sustaining).
• 5+ years of direct technical supervisory experience. 
• Must have technical experience working on complex electro-mechanical systems.
• Must be familiar with U.S. FDA GMP requirements for manufacturers and maintain the production operations in compliance with these requirements.
• Demonstrated reasoning ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Demonstrated ability to be a proactive and collaborative leader in a dynamic operations and engineering environment. 
• Excellent interpersonal and communication skills across all levels of the organization.
• Ability to deal with nonverbal symbolism (formulas, equations, graphs, etc.). Able to comprehend variety of abstract and tangible variables.
• Must be able to work in a dynamic, fast-paced environment with strong ability to establish technical and professional credibility.
• Must be able to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas.

MANAGERIAL RESPONSIBILITIES

• The Senior Quality Engineering Manager will be responsible for the hiring, development, and performance management of the various levels of engineers on the Quality Engineering team.  She/he will be responsible for planning, assigning, and managing work, developing training plans and the setting, and tracking annual goals and objectives. 

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
• The employee may occasionally lift and/or move up to up to 50 pounds. 
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
• The employee may occasionally lift and/or move up to up to 50 pounds.