Medical Device Senior Quality Assurance Engineer

Overview: Canon USA’s Healthcare Optics Research Lab collaborates with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Medical Device Senior Quality Assurance Engineer (Sr Engineer, Quality Assurance) will contribute from feasibility to the commercialization of new products. The Medical Device Senior Quality Assurance Engineer will ensure that work is aligned and compliant with international standards, regulatory requirements, quality management systems and project goals including risk assessment, design assurance, product and process validation and verification. The Medical Device Senior Quality Assurance Engineer will support research and development projects involving software, mechanical and electrical elements. This position is full time and offers a hybrid work schedule requiring you to be in the office three days per week and an option to work from home two days per week. Note that work schedules and office reporting requirements may change from time to time based on business needs. Responsibilities: - Collaborate with cross-functional product development teams including project managers, optical engineers, mechanical engineering, electrical engineers, software engineers, manufacturing engineers, regulatory specialists, clinical specialists, marketers, buyers, and others - Participate in the design review process to ensure that designs meet requirements and project goals - Oversee risk management activities including risk assessment, software risk assessment, design and process FMEA - Lead Quality Engineering functions during design validation and design verification - Review change management of all aspects of design - Review development and execution of complex experiments and tests (including protocols) for test method validation and process validation - Support Quality Management System activities as needed including supplier management, document control and standards management - Ability to travel up to 10% domestically as needed Results Expected: - Support for creation and maintenance risk management documents - Represent Quality Engineering during all phases of product development including risk assessment, design reviews, change management, and verification and validation - Support for qualification, execution and improvement of quality systems and tools Qualifications: Please note: We comply with all applicable federal, state and local laws, regulations, orders and mandates, including those we may be required to follow as a federal government contractor/subcontractor. - Bachelor’s degree or higher in an engineering discipline required - At least five (5) years of experience in medical device quality engineering - At least three (3) years of experience in new product development quality engineering, including time working with contract manufacturers/vendors working with electronics testing, and/or catheter manufacturing is strongly preferred - Proven track record in design quality engineering experience - Technical expertise in quality engineering - Proficient in the use of statistical methods - Design Assurance experience is required - Product Software experience a plus - Strong proficiency with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent) - Quality Engineer certification (CQE) preferred The company will not pursue or support visa sponsorship for this position. Company Overview: About our Company - Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $30.3 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2022† and is one of Fortune Magazine's World's Most Admired Companies in 2022. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA.

†Based on weekly patent counts issued by United States Patent and Trademark Office.
All referenced product names, and other marks, are trademarks of their respective owners.

Canon U.S.A., Inc. offers a competitive compensation package including medical, dental, vision, 401(k) Savings Plan, discretionary profit sharing, discretionary success sharing, educational assistance, recognition programs, vacation, and much more. A more comprehensive list of what we have to offer is available at https://www.usa.canon.com/about-us/life-at-canon/benefits-and-compensation

We comply with all applicable federal, state and local laws, regulations, orders and mandates, including those we may be required to follow as a federal government contractor/subcontractor.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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