Medical Device Senior Systems Engineering Manager

Location: US-MA-Cambridgen Requisition ID: 24323n Category: Medical Devicen Position Type: Full-Timen n Overview n nCanon USA’s Healthcare Optics Research Lab is a young organization that is gaining momentum.

We are partnering with world class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products.

The Medical Device Senior Systems Engineering Manager (Sr Manager, Systems Eng) at Canon USA Healthcare Optics Research Lab will be responsible for leading the systems engineering team for design, implementation and verification of innovative medical imaging systems in collaboration with world’s leading medical institutions.

This is a highly visible role where you will join the project leadership team having an opportunity to directly interact with key stakeholders including KOLs and world-class researchers.

We are seeking a highly-motivated, execution-focused leader with the ability to define roles and activities necessary for a successful product commercialization.

n n Responsibilities n n
– Plans and Directs the systems development function, including the engineering design and development of complex medical device, including electrical, optical, mechanical and software design activities from definition phase through product launch.

Responsible for overseeing and directing the activities of the engineering teams engaged in troubleshooting, debugging software programs and modifying module and systems for commercial product of medical devicesn
– As people-oriented leader, build and establish a high-performance system engineering team by developing, mentoring and coaching each engineer.

Inspire and motivate the team members to achieve individual and project goals.

Analyze, evaluate and plan approaches on complex technical challenges.

Selects, develops and evaluates direct-report employeesn
– Analyze, evaluate and plan approaches on complex technical challenges.

Responsible for designing, developing, modifying and evaluating electronic parts, components or integrated circuitry for electronic equipment and determines hardware systems compatibility and/or hardware designn
– Demonstrate strong system engineering knowledge and expertise within FDA regulated industries, good judgment and timely decision-making by providing leadership to project team members and commits resources to execute specific project tasks.

Working from an established mastery of 21 CFR Part 820, lead the team through all Design Control phasesn
– Coordinate project work with functional and external stakeholders with a solid understanding of overall project goals, schedule, and deliverables.

Demonstrate strong and clear accountability for project success.

Create and effectively manage budget and resource allocation within the organizationn
– Interface and collaborate with group companies including software engineering and manufacturing.

Build and maintain relationships with key vendors and assist with technical aspects of vendor negotiationsn
– Work effectively in cross-functional teams consisting of Clinical, Design & Usability, Marketing, R&D, Quality, and Regulatory.

Collaborate with other functions to build infrastructure for effective product development of medical devices.

Ensure compliance with Canon quality policies, procedures, and practicesn
– Provide leadership and guidance for novel inventions for patent applicationsn
– Report progress regularly to Upper Management.

Manages a functional area (such as a department or region) and ensures goals, deadlines and budgets are met for area of responsibility.

As the bridge between strategy and operations, is responsible for establishing annual objectives and for planning projects, initiatives, policies or program changes that are necessary to support the strategic goals established at higher levelsn
– May provide input to strategy development.

Has in-depth knowledge of organizational objectives and interacts regularly with other senior managers across the organization.

Typically reports to a Director or Senior Director n n Qualifications n n
– Bachelor’s degree in a relevant field or equivalent experience required, plus 10 years of related experience and at least 5 years of management of 2 or more regular full-time employeesn
– Strong technical knowledge of system integration based on electrical engineering, both tools and processes, is requiredn
– Experience in project management of medical devices under Design Control (21 CFR Part 820) and ISO 14971, with compliance to IEC 60601, is strongly preferredn
– Experience leading teams with external design, development and manufacturing partnersn
– Must be comfortable working in a multi-functional matrixed organization under the Quality Systemn
– Experience in intellectual property developmentn
– Excellent oral and written communication skills with the ability to communicate clearly to upper management and other stakeholders in different functions at various levelsnThe company will not pursue or support visa sponsorship for this position.

n n Company Overview n nAbout 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 $36 billion in global revenue, its parent company, Canon Inc.

(NYSE:CAJ), ranks third overall in U.S.

patents granted in 2018† and is one of Fortune Magazine’s World’s Most Admired Companies in 2019.

Canon U.S.A.

is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States.

Canon U.S.A.

is dedicated to its Kyosei philosophy of social and environmental responsibility.

In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings.

To keep apprised of the latest news from Canon U.S.A., sign up for the Company’s RSS news feed by visiting and follow us on For media inquiries, please contact .

n n† Based on weekly patent counts issued by United States Patent and Trademark Office.

n All referenced product names, and other marks, are trademarks of their respective owners.

n nWe are an EEO/AA employer.

Minority/Female/Individuals with Disabilities/Protected Veterans.n nIf you are not reviewing this job posting on our Careers’ site , we cannot guarantee the validity of this posting.

For a list of our current postings, please visit us at .n n#CUSA n n Posting Tags n n#PM19 #LI-AV1 #CUSAn n nnPInn