Staff Mechanical Engineer – Design Quality

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 Mechanical Engineer – Design Quality 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 electrical design quality assurance, testing, 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, design changes to existing products, and CAPAs/Audits in ensuring compliance with company’s Quality Management System. 
• Understands root cause investigation process and able to initiate routine problem-solving investigations.
• Support Electrical Safety and EMC standards and testing (IEC 60601-1, IEC 60601-1-2) and determining root-cause and resolving issues in complex electro-mechanical systems
• Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files
• Develop and implement product quality plans and risk management plans to ensure a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes. 
• Demonstrate leadership and expertise in mechanical development especially for hazard analysis/failure mode effects analysis (FMEA) and participate in the formal release process for medical devices satisfying quality and regulatory requirements. 
• Collaborate with engineers in mechanical, firmware, software, test, and other fields to build innovative solutions and ensure requirements and specifications are met the compliance needs.
• Participate in refining mechanical engineering design of current generation products.
• Support biocompatibility/cleaning validation/sterilization assessment/testing, Usability Testing, and IEC 60601 Testing Activities
• Understand and adhere to the PROCEPT BioRobotics and other applicable international quality system standards. 
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System & EHS to ensure product and support regulatory compliance
• Understand and adhere to the PROCEPT BioRobotics Quality & EHS policies

QUALIFICATIONS (Education, Experience, Certifications)

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
• Bachelor’s degree or master’s degree in, Mechanical Engineering
• Minimum of 10 years of related experience with a bachelor’s degree; or 8 years and a master’s degree; or a PhD with 3 years’ experience; or equivalent experience in medical devices industry.
• Working knowledge of CFR 21 820, ISO 13485, ISO 14971, IEC 10993, IEC 60601 standards and ROHAS/REACH compliance
• Implementation GD&T and tolerance analysis in mechanical design outputs
• ASQ QE, Lead Auditor certifications preferred
• Must be detail oriented, well organized and have excellent communication skills
• 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
• Experience in working with internal MFG or external CM partners on NPI MFG process, testing protocol