Design Quality Engineer - Capital

Company OverviewEmbark 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!

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 Files
• Implement 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 60601-2-37 etc.
• Contribute to Engineering drawings and become an effective liaison between design teams, Receiving Inspection, suppliers, manufacturing and other quality functions
• Consult with product development to evaluate system interfaces, operational requirements, and performance requirements of the overall system
• Serve as a technical design quality resource for requirements, risk, verification and validation, process validation, usability, human factors, statistical analysis, Design Transfer
• Partner and support activities involving complaint investigation, CAPA, NCMR, SCAR etc. for Capital Equipment
• Demonstrate critical thinking, effective cross-functional collaboration and advocates for decisions that preserve critical to quality attributes
• 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 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 standards
• Detail oriented, well organized and have excellent communication skills
• Flexibility and adaptability to accept new tasks

The Qualifications We Would Like You to Possess

• Experience with Ultrasound equipment and basic understanding of ultrasound related standards
• Good 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 public
• Contribute to regulatory filings for FDA and international agencies (EU, Japan etc.) as required

For US-Based Candidates OnlyWork 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 CultureAt 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