Design Quality Engineer - Capital

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:    Are you looking to be part of an enthusiastic, driven, and passionate team, who continuously learn from one another and solve complex challenges? Are you detailed oriented? Imagine what you could do here. At PROCEPT BioRobotics, you will be part of a dream-team to work on a surgical robot that combines real time data, multi-dimensional imaging, and robotics to remove prostate tissue. 
As we expand, you will contribute to the design quality deliverables for current and next generation robotic surgery platform. You will collaborate with cross functional teams to develop Design Quality strategies for worldwide approval in compliance with the company's Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards.
Get ready to transform lives and shape the future of BPH!
\n What Your Day-To-Day Will Involve:Support new Electromechanical product development and design changes to existing products in ensuring compliance with PROCEPT's Quality System leading to delivery of robust Design History FilesImplement product design quality and risk management plans to ensure a high degree of assurance to 21CFR820, ISO 13485 and ISO 14971 to produce a product that meets specifications and critical to quality attributes. Support PROCEPT-BioRobotics' Capital Equipment including Electromechanical design, development, documentation, and testing activities at system and sub-system level per IEC 60601, IEC 62304, IEC ******** etc.Contribute to Engineering drawings and become an effective liaison between design teams, Receiving Inspection, suppliers, manufacturing and other quality functionsConsult with product development to evaluate system interfaces, operational requirements, and performance requirements of the overall systemServe as a technical design quality resource for requirements, risk, verification and validation, process validation, usability, human factors, statistical analysis, Design TransferPartner and support activities involving complaint investigation, CAPA, NCMR, SCAR etc. for Capital EquipmentDemonstrate critical thinking, effective cross-functional collaboration and advocates for decisions that preserve critical to quality attributesMaintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory complianceUnderstand and adhere to the PROCEPT BioRobotics EHS policy The Qualifications We Need You to PossessBachelor's degree in Mechanical, Electrical or Biomedical Engineering 2+ years of experience working in medical device industry with experience in Capital Equipment, Electromechanical device Working knowledge of ISO 13485, ISO 14971, IEC 60601 standardsDetail oriented, well organized and have excellent communication skillsFlexibility and adaptability to accept new tasks The Qualifications We Would Like You to PossessExperience with Ultrasound equipment and basic understanding of ultrasound related standardsGood understanding of statistical analysis inclusive of regression, MTTF, Reliability etc. Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general publicContribute to regulatory filings for FDA and international agencies (EU, Japan etc.) as required
\nFor US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role, the anticipated base pay range is $92,000-128,000 per year.
Plus, eligibility for an annual bonus and equity/RSUs.
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 is listed below and represents 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.