Quality Engineer - NPI - Disposables and Accessories
Quality Engineer - NPI - Disposables and Accessories
Posted on :
16-05-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
16-05-2025
Job Description
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:
Quality Engineer plays a critical role in supporting the design and development of innovative surgical robotics technologies ensuring compliance with PROCEPT BioRobotics Quality Management System and applicable regulatory requirements. This role collaborates crossfunctionally with Engineering Program Management and Regulatory teams to ensure robust product development risk management and design control practices are followed throughout the product lifecycle.
What Your DayToDay Will Involve:
- Contribute to design modifications for existing disposables and accessory products to ensure alignment with PROCEPTs Quality System.
- Support risk management activities including updating risk documentation and gathering risk data for monthly and quarterly reviews.
- Act as a technical resource across requirements development risk analysis verification and validation (V&V) and design transfer processes.
- Provide engineering support to PROCEPTBioRobotics design and development efforts with a primary focus on biocompatibility sterilization and stability testing
- Collaborate closely with thirdparty test laboratories to ensure the accuracy and completeness of all submitted information for final reports
- Assist Program Management in ensuring adherence to Design Control and Risk Management procedures and in the creation of Design History Files (DHFs).
- Support the implementation of master verification and validation plans as well as own risk management plans to ensure that product designs and processes consistently meet specifications and criticaltoquality attributes.
- Collaborate with the QA department during quality audits including those conducted by the FDA and Notified Bodies and assist in addressing nonconformances.
- Participate in corrective and preventive actions (CAPA) related to product design and quality assurance.
- 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 & EHS policies
The Qualifications We Need You to Possess:
- Bachelors degree in mechanical engineering biomedical engineering or related discipline.
- 2 years of experience in a design quality product development or medical device environment.
- Working knowledge of FDA regulation (21 CFR Part 820) MDSAP and international standards such as ISO 13485 ISO 14971 ISO 11607 ISO 10993 and ISO 11135.
- Strong understanding of design control processes risk management and quality assurance in medical devices.
- Experience with verification and validation planning execution and documentation.
- Excellent communication organizational and problemsolving skills.
- Ability to work effectively in a crossfunctional environment.
$100000 $118000 a year
Compensation also includes a yearly 10% bonus and RSUs at offer!
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 crossfunctional team building an immersion in Procepts history jampacked interactive sessions with executive leadership and a crashcourse in the mission and purpose of what we do. It continues with our oneofakind 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 onsite gym a 401(k) plan with employer match shortterm and longterm 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 noncommissionable roles or ontarget earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to jobrelated 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.
Employment Type
Full-Time
Key Skills
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