Quality Engineer Capital Equipment

PROCEPT BioRobotics

Job Location:

San Jose, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 andare 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 FDAs 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:

Participate in and Support new product development and design changes to existing products in ensuring compliance with companys Quality System.
Serve as a technical resource for requirements risk verification and validation process validation usability statistical analysis Design Transfer etc.
Support PROCEPT-BioRobotics Capital Equipment design development with primary focus on electrical and software systems evaluating reliability and ensuring quality requirements are met.
Lead Facilitate or Support risk management activities including hazard analysis/failure mode effects analysis (FMEA) and participate in the formal design and production release process for medical devices.
Collaborate with cross-functional engineers (e.g. mechanical electrical systems test and others) to ensure requirements and specifications meet product performance safety and compliance nees.

Support verification validation and compliance testing including usability testing electrical safety testing (e.g. IEC 60601) and system validation

Develop and implement product quality plans and risk management plans as needed to ensure designs and processes consistently meet product specifications and critical to quality attributes.
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 activities
Partner with manufacturing engineers to review and improve manufacturing documentation to ensure manufacturability serviceability testability reliability and compliance with product requirements
Support continuous improvement initiatives through failure investigations root cause analysis and resolution of non-conformances.
Support or implement manufacturing test equipment and diagnostics to identify product failures causes and improve detection of defects.
Contribute to and support the Corrective and Preventative Action (CAPA) Program 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.
Define and support for in-process inspections and release testing including statistical sampling strategy and test methods.
Maintain product risk management files and support ongoing process and product FMEA activities.
Establish support and maintain process control and statistical process controls (SPC) for production processes.
Ensure production personnel maintain compliance with training requirements and quality procedures.
Collaborate with Supplier Engineering to resolve supplier related quality issues.
Audit maintain and ensure accuracy of the Device Master Record (DMR) or Medical Device File
Drive review and disposition of Returned Good Authorization (RGA)
Support complaint investigations and post market quality activities as required
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

Bachelors degree in engineering (Biomedical/Electrical/Mechanical) or related field plus 2-5 years of related experience in quality or manufacturing.
A working knowledge of the FDA Quality System Regulation CFR820 ISO 13485 ISO 14971 IEC62304.
Experience in conducting product Investigations.
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

The Qualifications We Would Like You to Possess

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

$102000 - $119280 a year

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role the anticipated base pay range is 00 per year.

Plus eligibility for an annual bonus and equity/RSU

Understanding PROCEPTs 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 résumé 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: .

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Company OverviewEmbark 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 andare committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known...