Senior Quality Engineer - Capital Equipment at PROCEPT BioRobotics – San Jose, California
PROCEPT BioRobotics
San Jose, California, 95101, United States
Posted on
NewSalary:$102000 - $119280Job Function:Engineering
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About This Position
Senior Quality Engineer - Capital Equipment
What Your Day-To-Day Will Involve:
The Qualifications We Would Like You to Possess
$102,000 - $119,280 a year
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 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 Medical device Quality Engineering team as a Senior Quality Engineer. 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.
• Participate in and support new product design transfer through commercialization and design change transfers to existing products in ensuring compliance with company’s Quality System with primary focus on electrical and software systems, evaluating reliability and ensuring quality requirements are met.
• Facilitate, or Support risk management activities specifically process FMEA and participate in the formal design and production release process for medical devices.
• Ensure appropriate inspection and testing strategies for electrical assemblies, firmware loading, and system-level production acceptance testing.
• Represent Quality function within Capital Equipment Production and Service Operations, ensuring standards are maintain across the product lifecycle.
• Establish and maintain master validation program, including site and individual products and process master validations (IQ/OQ/PQ) activities
• Partner with manufacturing engineers to review and improve manufacturing documentation to ensure manufacturability, serviceability, testability, reliability, and compliance with product requirements
• Define and support for in-process inspections, and release testing, including statistical sampling strategy and test methods.
• Audit, maintain, and ensure accuracy of the Device Master Record (DMR) or Medical Device File
• Ensure production personnel maintain compliance with training requirements and quality procedures.
• Support regulatory inspections and notified body audits.
• Support continuous improvement initiatives through failure investigations, root cause analysis, and resolution of non-conformances.
• Contribute to and support the Corrective and Preventative Action (CAPA) Program, complaint investigations ensuring timely investigation, corrective actions, and effectiveness verification.
• Participate in supplier quality activities, including material issue resolution, coordination of Material Review Board (MRB) decisions for non-conforming products.
• Collaborate with Supplier Engineering to resolve supplier-related quality issues.
• Maintain training and compliance with all aspects of the PROCEPT BioRobotics Quality Management System.
• Understand and adhere to the PROCEPT BioRobotics Quality and Environment Health and Safety (EHS) Policies.
The Qualifications We Need You to Possess• Facilitate, or Support risk management activities specifically process FMEA and participate in the formal design and production release process for medical devices.
• Ensure appropriate inspection and testing strategies for electrical assemblies, firmware loading, and system-level production acceptance testing.
• Represent Quality function within Capital Equipment Production and Service Operations, ensuring standards are maintain across the product lifecycle.
• Establish and maintain master validation program, including site and individual products and process master validations (IQ/OQ/PQ) activities
• Partner with manufacturing engineers to review and improve manufacturing documentation to ensure manufacturability, serviceability, testability, reliability, and compliance with product requirements
• Define and support for in-process inspections, and release testing, including statistical sampling strategy and test methods.
• Audit, maintain, and ensure accuracy of the Device Master Record (DMR) or Medical Device File
• Ensure production personnel maintain compliance with training requirements and quality procedures.
• Support regulatory inspections and notified body audits.
• Support continuous improvement initiatives through failure investigations, root cause analysis, and resolution of non-conformances.
• Contribute to and support the Corrective and Preventative Action (CAPA) Program, complaint investigations ensuring timely investigation, corrective actions, and effectiveness verification.
• Participate in supplier quality activities, including material issue resolution, coordination of Material Review Board (MRB) decisions for non-conforming products.
• Collaborate with Supplier Engineering to resolve supplier-related quality issues.
• Maintain training and compliance with all aspects of the PROCEPT BioRobotics Quality Management System.
• Understand and adhere to the PROCEPT BioRobotics Quality and Environment Health and Safety (EHS) Policies.
- Minimum 5 years with a Bachelor's degree or 3 years and a Master’s degree preferably in an engineering or scientific discipline from a four-year college or university (e.g. Biomedical/Electrical)
- 3-5+ years related experience in quality, manufacturing, or engineering in a regulated environment (medical device preferred).
- Background in electromechanical and embedded software devices.
- A working knowledge of the FDA Quality System Regulation CFR820, ISO 13485, ISO 14971, IEC62304.
- Must be detail-oriented with strong written and oral communication skills.
- 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 public.
- Must have a working knowledge of statistics.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists
- 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 102,000-119,280 per year.
Plus, eligibility for an annual bonus and equity/RSU
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 doesnt happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procepts 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 wont 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!
PROCEPTs 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
Well 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.
PROCEPT BioRobotics Applicant Privacy Notice
When you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, rsum or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role.
To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy].
$102,000 - $119,280 a year
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Job Location
San Jose, California, 95101, United States
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