The Role
The Sr. Quality Engineer will develop inspection methods, collaborate across departments, validate testing, and enhance quality processes for incoming materials in a medical device manufacturing environment.
Summary Generated by Built In
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and 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 Quality Shared Services team is seeking a motivated and collaborative individual to create the
component inspection methods at PROCEPT BioRobotics. This role would also support building and
maintaining scalable processes in incoming quality control. The Sr. Quality Engineer would lead
identification, implementation, and execution of test and inspection method for all incoming quality
activities. Additionally, in coordination with the stakeholder team the role will assist in the development
of inspection techniques using automated equipment and support and validation activities. 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 inspection methods for components by seeking input from Engineering, including fixturing, programming automated equipment, as well as executing mock repeatability and reproducibility studies
- Support execution of receiving inspection test method validations(TMV) Gauge R&R Studies, Attribute Analysis Studies, Engineering Studies, and any other required validation/qualification work for Receiving Inspection methods and maintain compliance
- Collaborate with Manufacturing, Quality, Regulatory, and R&D to develop component inspection plans.
- Develop automated inspection methods, including CMM programs, tools and fixturing, to increase productivity and throughput of the RI team.
- Document and maintain library of inspection methods for each part including programs for automated inspection equipment in the PROCEPT document management system.
- Perform equipment related validations. Maintain validated state of inspection methods, equipment, tools and fixtures required for receiving inspection activities in collaboration with TMV QE.
- Act as the liaison for the RI team with the equipment team to ensure calibration and preventive maintenance status for tools and equipment remain in compliance with requirements. Address related nonconformances in a timely manner.
- Support NPI projects by leading the design and validation of innovative and robust inspection methods that will be used for incoming materials or engineering evaluations.
- Review inspection Equipment/ tool specifications for suitability and applicability to the materials
- Implement automated data collection and analysis tools for inspection methods used in RI
- Provide IQC lab support for all test equipment related issues.
- Educate receiving inspection team on the inspection methods and equipment used as part of our quality system.
- Develop/ update test method work instructions (WIs),Quality Instructions (QIs),and standard operating procedures (SOPs) as needed/ assigned.
- Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
- Ensures receiving and in-process 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.
- 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 Engineering, Manufacturing Operations, Supplier Engineering,
- Supplier Quality Engineering Groups with quality meetings, problem solving, and reject/defect investigations associated with purchased parts.
- Own RINCMRs and manage recurring meetings with cross functional teams to ensure timely closure of investigations, root causes.
- Support the NCMR process owner and the MRB coordinator as back up shared service representative.
- Work related travel (Domestic and overseas) 5%
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).
- Strong organizational skills, detail oriented. Exceptional verbal and written communication skills.
- Ability to collaborate within an organization across all functional departments (e.g. Legal,
- Regulatory with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
- Abilitytoleadcrossfunctionaldiscussionand“getthejobdone”attitudeinafast-paced
- environment.
- Working knowledge of Quality System within the requirements of FDA's Quality System
- Regulation (QSR), ISO13485 (ISO) and EU MDR.
- A 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.
For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident
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 represents a 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.
Top Skills
Automation Equipment
Cmm Programs
Inspection Tools
MS Office
Quality Improvement Tools
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The Company
What We Do
PROCEPT BioRobotics is a commercial-stage surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell the AQUABEAM Robotic System, an advanced, image-guided, surgical robotic system for use in minimally-invasive urologic surgery with an initial focus on treating benign prostatic hyperplasia, or BPH. Our proprietary AQUABEAM Robotic System delivers Aquablation therapy, which combines real-time, multidimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. Aquablation therapy delivers effective, safe and durable outcomes for males suffering from lower urinary tract symptoms, or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience.
