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Senior Systems Engineering Manager

Senior Systems Engineering Manager

Canon 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.

Responsibilities

  • 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 devices
  • 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 employees
  • 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 design
  • 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 phases
  • 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 organization
  • 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 negotiations
  • 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 practices
  • Provide leadership and guidance for novel inventions for patent applications
  • 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 leve
  • 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

Qualifications

  • 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 employees
  • Strong technical knowledge of system integration based on electrical engineering, both tools and processes, is require
  • Experience in project management of medical devices under Design Control (21 CFR Part 820) and ISO 14971, with compliance to IEC 60601, is strongly preferred
  • Experience leading teams with external design, development and manufacturing partners
  • Must be comfortable working in a multi-functional matrixed organization under the Quality System 
  • Experience in intellectual property development
  • Excellent oral and written communication skills with the ability to communicate clearly to upper management and other stakeholders in different functions at various levels
  • The company will not pursue or support visa sponsorship for this position. 

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