Design Quality Engineering Manager, Surgical Instruments

San Jose, CA - USA

Monthly Salary: Not Disclosed

Posted on: 6 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 anotherAre you a leader who wants to make a difference improve processes and inspire others to achieve challenging goals and objectives Are you detailedoriented At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with crossfunctional 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 selfmanaged will assist in the success of this position. Get ready to transform lives and shape the future of healthcare!

What Your Day-To-Day Will Involve:

The Design Quality Engineering Manager leads the ongoing quality deliverables for integration and development of multiple engineering disciplines for our robotic surgery platforms. This role will oversee the Design Quality team by developing and implementing indepth strategies and project plans to improve product qualification for robotic related single use devices consumables and accessories.
The candidate will work closely with the R&D and Manufacturing on Design quality assurance activities to ensure alignment across the organization.
The candidate will be responsible for developing design quality assurance and reliability strategies for worldwide approval to introduce new and/or modified products to market in compliance with the companys Quality Management System 21CFR820 ISO 13485 and other applicable international quality system standards.
Support new product development and design changes to existing products in ensuring compliance with companys Quality System
Lead Risk Management activities including improving the risk management process
Support design test and inspection method development and assist with design verification and validation testing
Develop and implement product quality plans product specifications risk management plans to ensure high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes
Develop and maintain procedures for UDI requirements and registration of devices
Update or submit product data information and work with third party service provider
The Design Quality Engineering Manager will be responsible for the hiring development and performance management of the Design Quality team.
Create apply and monitor performance metrics for personnel product and processes.
Collaborate cross functionally to Identify and implement projects that include but are not limited to reliability improvements process efficiency product manufacturability and cost reductions.
Plan annual budget to ensure resources are adequate to execute approved projects and goals.
Provide leadership coaching and development plans for all direct reports to maintain an engaged and productive workforce.
Drive projects through cross functional collaboration timeline and schedule management.
Prepare and issue timely status updates on active projects for review by Senior Management.
Assure compliance to all company policies standard operating procedures and recognized domestic/international standards.
Oversee the product development process and deploy applicable standard operating procedures for new product development and design changes to existing products.
Support corrective and preventive action process for design and quality assurance process related CAPA
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 EHS policy

The Qualifications We Need You to Possess

Bachelors degree in STEM or Quality related education or an engineering discipline required Masters degree preferred.
Minimum of 5 years of experience working in medical device industry
Experience leading technical teams and/or managerial supervisory experience preferred.
Must have working knowledge of CFR 820 ISO 13485 ISO 14971 IEC 60601-1
Strong understanding of ISO 14971
Have working knowledge of sterilization biocompatibility and transit/shelf-life standards
Must be detail oriented well organized and have excellent communication skills. Must work well with team
Must be able to accomplish objectives with minimal supervision
Experience in conducting product Investigations
ASQ CQE CQA Black Belt Six Sigma certification a plus
Demonstrated reasoning ability to apply principles of logical or scientific and critical thinking
Demonstrated ability to be a proactive and collaborative leader in a dynamic operations and engineering environment. This individual possesses a bias toward action and results (no stones left unturned).
Able to multitask establish clear expectations set objectives and deliver results within tight deadlines.
Must be able to work in a dynamic fastpaced environment with strong ability to establish technical and professional credibility and demonstrate MUSTDO attitude.
Must be able to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas.
Expected to present design quality related topics in the front room for regulatory audits (FDA MDSAP MDR)
Background in electromechanical and software devices
Must have a solid understanding of statistical processes and techniques
Ability to read analyzes and interprets general business periodicals professional journals technical procedures or governmental regulations
Ability to write reports business correspondence and procedure manuals
Ability to effectively present information and respond to questions from other internal groups clients customers and the general public
Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists
Ability to interpret a variety of instructions furnished in written oral diagram or schedule form

$162000 - $191000 a year

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:

Manager

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...