Quality Engineer - NPI - Disposables and Accessories

PROCEPT BioRobotics; San Jose (CA); On-site; USD 100,000 - 118,000; Full time

Job summary

Join a leading company in surgical robotics as a Quality Engineer, where you will ensure compliance with quality systems and collaborate with cross-functional teams. Your role will involve supporting product development and maintaining rigorous quality standards to enhance patient care.

Benefits

Full medical coverage

Wellness programs

On-site gym

401(k) plan with employer match

Paid parental leave

Flexible or paid time off

Paid holidays

Qualifications

• 2 years of experience in a design quality or medical device environment.
• Working knowledge of FDA regulations and ISO standards.

Responsibilities

• Support design modifications and risk management activities.
• Collaborate with QA during audits and address non-conformances.
• Provide engineering support focusing on biocompatibility and testing.

Skills

Communication

Problem-Solving

Organizational Skills

Education

Bachelor’s degree in mechanical engineering

Bachelor’s degree in biomedical engineering

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 cross-functionally 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 Day-To-Day Will Involve:

• Contribute to design modifications for existing disposables and accessory products to ensure alignment with PROCEPT’s 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 PROCEPT-BioRobotics’ design and development efforts, with a primary focus on biocompatibility, sterilization, and stability testing
• Collaborate closely with third-party 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 critical-to-quality attributes.
• Collaborate with the QA department during quality audits, including those conducted by the FDA and Notified Bodies, and assist in addressing non-conformances.
• 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:

• Bachelor’s 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 problem-solving skills.
• Ability to work effectively in a cross-functional environment.

$100,000 - $118,000 a year

Compensation also includes a yearly 10% bonus and RSUs at offer!

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.