Senior Manager, Quality Engineering - Capital

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

Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you detailed oriented? Imagine what you could do here. At PROCEPT BioRobotics, the Senior Manager, Quality Engineering - Capital, will lead the capital quality engineering team to work on a surgical robot that combines real time data, multi-dimensional imaging and robotics to remove prostate tissue. As PROCEPT BioRobotics continues to expand, you will oversee the design quality deliverables for the next generation capital robotic surgery platform and for our current capital product generation. You will work with cross functional teams to develop design quality assurance and system level test strategies for worldwide approval in compliance with the company's Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide overall leadership of Capital equipment design control guidance to research and development teams and product life cycle teams.
• Be a core team member of Product Life cycle team(s).
• Review and approve documentation consistent with design control regulations and guidance’s dealing with systems development, verification and validation practices, and SOPs.
• Manage capital equipment design quality engineering team to ensure completeness of Design History File documents such as user requirements, product requirements, design and development plans, verification and validation plans and design transfer activities.
• Oversee the execution of system level verification testing, and be a key contributor on usability deliverables.
• Work with cross functional teams to access product labeling, new supplier selection, risk management plans, Hazard analysis, and dFMEA activities for capital equipment.
• Work with electrical and mechanical team to ensure safety compliance to IEC 60601 and machinery directives. 
• Work with project management team on QA design deliverables per project plan and milestone deliverables.
• Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality.
• Assist QA department in quality audits including FDA and Notified Body and respond to non-conformities, as necessary. 
• Establish and build relationships with internal and external partners to support strategic product initiatives.
• Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
• Provide input to quality budgeting including planning and managing to establish targets and plans. 
• 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 and EHS policies

QUALIFICATIONS

• 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.
• College Degree required, B.S. in Science, Engineering or equivalent combination of education and experience. M.S. preferred
• Experience working in a structured design process such as ISO13485 or FDA QSR, knowledge of regulatory approval process and requirements.
• Minimum 7+ years of relevant experience in medical devices industry with 5 years in leadership roles
• Experience working with electronic, software, and/or imaging devices is desirable
• Experience in managing the following standards/requirements: 
• ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
• European Union Medical Device Regulation (EU 2017/745)
• IEC 60601 standard and its collaterals
• IEC 62366 Usability standards
• Computer Skills: basic data analysis 
• Ability to work as part of a multi-disciplinary team in a small, faced paced company
• Ability to balance hands-on detailed design tasks and project management/planning functions.
• Experience with electronic QMS helpful. 

MANAGERIAL RESPONSIBILITIES

• Directly supervises employees in the Capital and System Quality Engineering Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.

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 is occasionally required to attend animal or cadaver labs and to manipulate models and/or organs for testing
• The employee occasionally packs and unpacks packages
• The employee may occasionally lift and/or move up to up to 25 pounds. 
• The employee will occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn. 
• The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
• The employee will occasionally be exposed to clinical operating rooms, for which proper personal protection equipment will be assigned and worn. 
• While performing the duties of this job, the employee is regularly working in a warehouse environment. 

For US Based Candidates Only

For this role, the anticipated base pay range is $165,000-$235,000 a year.

PROCEPT BioRobotics is committed to fair and equitable compensation practices and we aim to provide employees with total compensation packages that are market competitive. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate's qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. PROCEPT also offers a comprehensive suite of benefits including, but not limited to, health insurance plans, ESPP, 401k retirement savings plan with a company match, and paid time off programs. All compensation and benefits programs are subject to the discretion of the company.