jobr.pro
Design Quality Engineering Manager, Surgical Instruments
jobr.pro, San Jose, California, United States, 95199
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.
SUMMARY Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you detailed oriented? Imagine what you could do here. At PROCEPT BioRobotics, the Senior Manager, Quality Engineering - Capital, will lead the capital quality engineering team to work on a surgical robot that combines real-time data, multi-dimensional imaging and robotics to remove prostate tissue. As PROCEPT BioRobotics continues to expand, you will oversee the design quality deliverables for the next generation capital robotic surgery platform and for our current capital product generation. You will work with cross functional teams to develop design quality assurance and system level test strategies for worldwide approval in compliance with the company’s Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards.
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 in‑depth 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 company’s 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 company’s 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
Bachelor’s degree in STEM or Quality related education or an engineering discipline required, Master’s 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 multi‑task, establish clear expectations, set objectives and deliver results within tight deadlines.
Must be able to work in a dynamic, fast‑paced environment with strong ability to establish technical and professional credibility and demonstrate MUST‑DO 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
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.
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SUMMARY Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you detailed oriented? Imagine what you could do here. At PROCEPT BioRobotics, the Senior Manager, Quality Engineering - Capital, will lead the capital quality engineering team to work on a surgical robot that combines real-time data, multi-dimensional imaging and robotics to remove prostate tissue. As PROCEPT BioRobotics continues to expand, you will oversee the design quality deliverables for the next generation capital robotic surgery platform and for our current capital product generation. You will work with cross functional teams to develop design quality assurance and system level test strategies for worldwide approval in compliance with the company’s Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards.
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 in‑depth 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 company’s 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 company’s 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
Bachelor’s degree in STEM or Quality related education or an engineering discipline required, Master’s 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 multi‑task, establish clear expectations, set objectives and deliver results within tight deadlines.
Must be able to work in a dynamic, fast‑paced environment with strong ability to establish technical and professional credibility and demonstrate MUST‑DO 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
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.
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