Senior Manager

Company Overview

Embark 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:

Do you want to be part of an innovative, cutting-edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.

What Your Day-To-Day Will Involve:

• Leads Incoming Quality Control, and nonconforming materials processes.

• Single Point of Accountability for incoming inspection activities. Manage QC Supervisors and other quality inspection staff when needed.

• Own the NCMR process and manage recurring meetings with cross functional teams to ensure timely closure of investigations, root causes.

• Co-develop new in-process quality inspections and co-manage legacy ones with Mfg. Operations and Engineering.

• Ability to strategically redirect Direct Labor workforce based on production demand.

• Strong hands-on knowledge of ERP systems for data query and mining

• Excellent MS Excel skills (pivoting, formula filtering of large data set)

• Strong working knowledge of applied Statistics

• Excellent verbal, written, communication and presentation skills.

• Ability to lead cross functional discussion and “get the job done” attitude in a fast-paced environment.

• Ensures receiving inspections are established and maintained in accordance with internal procedures as well as external regulation.

• Establish and ensure timely completion of department goals and objectives.

• Develop and implement process and procedures to meet company growth and scalability.

• Experienced in developing and implementing strategies to automate incoming and in-process inspections.

• Work with cross functional groups to resolve quality issues associated with purchased parts including initial supplier contact, containment, and permanent corrective action cycle.

• Resolve technical challenges by using of advanced problem-solving skills (DMAIC)

• Support Engineering, Quality, Operations, Supplier Quality Engineering Groups with problem solving, and reject/defect investigations associated with purchased parts and oversee (NCMR) process.

• Work related travel (Domestic and overseas) 10 – 25%

• Working knowledge of Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR.

• 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.

The Qualifications We Need You to Possess

• ·Minimum bachelor’s degree, Engineering (STEM, Biomedical, Mechanical, Electrical Engineering or similar)

• Mechanical Design experience of complex components/assemblies a huge plus.

• 5+ years of hands-on progressive technical experience in Engineering, Manufacturing or Quality in a medical device manufacturing environment required (Class II or above Medical Device, industries in complex electro- mechanical devices such as disk drives/storage or heavily regulated electro-mechanical industries like Aerospace, Automobile).

• 5+ years of experience in management and managing quality control personnel preferred.

• Minimum 3 years of experience defending regulatory audits in the front room.

• Excellent working knowledge of Geometric Dimensioning and Tolerancing (GD&T),

• Extensive working knowledge of xFMEA, Control Plan, Statistical Process Control (SPC), Containment Plans, CAPA, Measurement Fixture Development, Gage R&R, Test Method Validation

• Working knowledge of quality improvement tools and techniques

• Ability to read the room and adjust communication style in large audience meetings.

• ASQ CQE certification a plus.

• Working knowledge of process validation a plus.

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $171,000 - $214,000 per year.

Plus, eligibility for an annual bonus and equity/RSUs.

Understanding PROCEPT's Culture

At 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 cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

BENEFITS OF WORKING AT PROCEPT!

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.