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:
The Quality shared services team is seeking a motivated and collaborative individual to validate the component inspection methods at Procept. This role would also support building and maintaining scalable processes in incoming quality control. The Sr. QE would lead identification, implementation, and execution of test and inspection method validations for all incoming quality activities. Additionally, in coordination with the leadership team the role will assist in the development and validation of inspection techniques using automated equipment. An engineer with a passion for increasing inspection efficiency through use of automated testing/ measurement equipment would be an ideal candidate for the role. The Senior Quality Engineer will need to be creative and quality driven, as they will be required to work on projects that range from evaluation and validation of all our current test methods to development of entirely new inspection and test equipment. The work will include test method development/qualification/validation, data collection and analysis, and more. This is an exciting, fast-paced role at a fast-growing company that requires a hands-on and go-getter attitude!
What Your Day-To-Day Will Involve:
- Develop, and validate incoming quality inspection methods.
- Plan and execute test method validation (TMV) by completing/leading Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, Engineering Studies, and any other required validation/qualification work for Receiving Inspection methods and maintain compliance
- Validate programs and maintain program library for automated inspection equipment
- Support NPI projects by leading the design and validation of innovative and robust test methods that will be used for incoming material inspections.
- Develop new and innovative test methods that drive defect identification as early in the process as possible including providing oversight of supplier test method validations for purchased materials/ components.
- Write test specifications for automated measurement /inspection equipment and leverage internal partners to conduct SW validations for the inspection equipment and inspection methods.
- Review inspection Equipment/ tool specifications for suitability and applicability to the materials being evaluated
- Through data analysis, proactively identify and resolve test/inspection related issues throughout product build cycles.
- Provide IQC lab support for all test equipment related issues.
- Educate receiving inspection team on the test methods and equipment used as part of our quality system.
- Write and review Quality Instructions (QIs).
- Perform root cause analysis of test related issues, executing actions as needed.
- Work with the R&D and NPI teams to identify and incorporate design for test optimizations.
- Oversee product test specifications and applicable test equipment requirements for new products.
- Take ownership of all receiving inspection test equipment, acting as the responsible person for all test equipment issues.
- Develop/update test method work instructions (WIs) and standard operating procedures (SOPs) as needed.
- Collaborate with Manufacturing, Quality, Regulatory, and R&D to develop test engineering solutions.
- 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 EHS policy
The Qualifications We Need You to Possess
- Bachelor of Science in Engineering or combination of relevant education and experience.
- 4+ years relevant experience in medical device manufacturing.
- Experience in medical device manufacturing and with strong working knowledge of cGMPs.
- Manufacturing or Quality Engineering experience.
- Experience with Test Method Validation and/or Measurement System Analysis (i.e. Gauge R&R).
- Experience with fixture/equipment development.
- Experience with equipment qualification (FAT/SAT/IQ/OQ/PQ).
- Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred).
- Demonstrated knowledge of Project Management principles.
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
- Strong organizational skills, detail oriented. Exceptional oral and written communication skills.
- Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
For US-Based Candidates Only
For this role, the anticipated base pay range is $ 120,000 - $ 151,000 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.