Quality Engineer @ PROCEPT BioRobotics

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 Capital Operations 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:

Represent Quality in Capital Equipment Production and Service Operations
Establish and maintain master validation program, including site and individual products and process master validations activities
Work closely with manufacturing engineers to review and modify manufacturing process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality requirements
Support manufacturing engineers on continuous product and process improvement through detailed failure analysis for nonconformance’s.
Support or implement manufacturing test equipment to identify failure causes/symptoms.
Participate in supplier material related issues which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products
Support requirements for in-process inspections, and lot release testing, including statistical sampling strategy and test methods.
Implement effective and compliant solutions for manufacturing quality process corrections, retrospective and remediation action plans, and for corrective and preventive actions.
Assist with the development and maintenance of product process FMEA activities and maintenance of product risk management files.
Establish and maintain process controls/SPC for specific production processes.
Ensure compliance of the capital production personnel to the training program.
Collaborate with Supplier Engineering on supplier issues
Audit and maintain Device Master Record
Drive, review, and disposition of Returned Good Authorization (RGA)
Support complaint handling as required
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

The Qualifications We Need You to Possess

Bachelor’s degree.
2+ years related experience and/or training, or equivalent combination of education and experience
A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971.
Familiarity with test methods process verification, and capital production
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
Must have a working knowledge of statistics .
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

The Qualifications We Would Like You to Possess

BS Engineering (STEM, Biomedical, Mechanical, Electrical Engineering or similar) from a four-year college or university.
Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear.
EU Medical Device Directive is a plus

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $92,000- 116,000 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.

Quality Engineer

Capital Equipment

PROCEPT BioRobotics

Compensation Overview

What Your Day-To-Day Will Involve:

The Qualifications We Need You to Possess

The Qualifications We Would Like You to Possess

6 month growth

1 year growth

2 year growth

Simplify's Take

What believers are saying

What critics are saying

What makes PROCEPT BioRobotics unique

Benefits