Staff Design Quality Engineer

: PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company's AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. 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 Staff Design Quality Engineer will be part of a 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 robotic surgery platform and for our current product generation. You will work with cross functional teams to develop design quality assurance and reliability strategies for worldwide approval in compliance with the company's Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards.

CORE RESPONSIBILITIES

• Support new product development and design changes to existing products in ensuring compliance with PROCEPT's Quality System.
• Support Risk Management activities including improving the risk management process and maintenance of the Risk management procedure.
• Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer.
• Create and review System level verification and validation test protocols and test reports for Robotic System.
• Support PROCEPT-BioRobotics' design and development activities primarily focusing on Mechanical and Electrical design and may assess the reliability of new designs.
• Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files.
• Support implementation of product quality plans, 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.
• Support ROHS/REACH compliance effort.
• Assist QA department in quality audits including FDA and Notified Body and respond to non-conformities, as necessary.
• 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 Quality and EHS policies.

QUALIFICATIONS (Education, Experience, Certifications)

• Bachelor's degree in Mechanical or Biomedical Engineering.
• minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience; or equivalent experience.
• Must be detail oriented, well organized and have excellent communication skills.
• Must work well with team.
• Ability to manage multiple projects at the same time.
• Ability to write reports, customer facing correspondence, and procedure manuals.
• Understanding of electromechanical and software devices.
• Must be detail-oriented with strong written and oral communication skills.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Flexibility and adaptability to accept new tasks.
• Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public.
• Biocompatibility, EO sterilization and packaging validation experience desirable.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is occasionally required to attend animal or cadaver labs and to manipulate models and/or organs for testing
• The employee occasionally packs and unpacks packages
• The employee may occasionally lift and/or move up to up to 25 pounds.
• The employee will occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
• The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
• The employee will occasionally be exposed to clinical operating rooms, for which proper personal protection equipment will be assigned and worn.
• While performing the duties of this job, the employee is regularly working in a warehouse environment.

For US Based Candidates Only For this role, the anticipated base pay range is $150,000 - $207,000 a year. PROCEPT BioRobotics is committed to fair and equitable compensation practices and we aim to provide employees with total compensation packages that are market competitive. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate's qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. PROCEPT also offers a comprehensive suite of benefits including, but not limited to, health insurance plans, ESPP, 401k retirement savings plan with a company match, and paid time off programs. All compensation and benefits programs are subject to the discretion of the company.