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Medical Device Operations Director

Medical Device Operations Director

Canon USA’s Healthcare Optics Research Lab is collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. We are developing biomedical optical imaging and medical robotics technologies. Reporting to the Vice President/General Manager, the Operations Director (Director, Operations) will be responsible for all aspects of manufacturing and operations at Canon USA Healthcare Optics Research Lab. In addition, the individual will be responsible for leading the design for manufacturing and manufacturing transfer of new products that include complex systems and disposables from research & development. This is a highly visible role where you will join a leadership team of an innovative start-up organization in a global technology company. We are seeking a highly motivated, execution-focused leader with the ability to define roles and activities for successful product commercialization. 

Responsibilities

  • Establish a high-performance operation team by developing, mentoring and coaching each member as appropriate
  • Inspire and motivate the team members to achieve individual and project goals
  • Develop operation strategies and plans working with internal and external stakeholders
  • Scale manufacturing processes and units to volume per plan
  • Negotiate contracts and manage contract manufacturers collaborating with legal, quality, regulatory, and engineering
  • Lead and/or conduct all aspects of manufacturing engineering including: process validations activities, process development, and yield improvements
  • Lead new product design transfer and introduction to manufacturing ensuring smooth transition of new product introduction and product changes
  • Led purchasing efforts to ensure a stable supply chain and inventory levels. Evaluate and manage suppliers
  • Develop and manage service organization
  • Enforce good manufacturing practices (GMP) compliance with and adherence to Canon’s Quality Management System (QMS)
  • Work effectively in cross-functional teams consisting of Clinical, Design & Usability, Marketing, R&D, Quality, and Regulatory, and operation
  • Drive continuous improvement of operation
  • Establish goals for performance and report progress regularly to upper management

Qualifications

  • Bachelor’s Degree in Engineering
  • 12+ years of experience in medical device industry
  • 12+ years of management experience in operation with strong understanding of design for manufacturing of new products
  • Hands-on experience in medical device development and manufacturing
  • In-depth knowledge in regulatory affairs and quality assurance
  • Experience of developing supply chains for new products from ground up
  • Experience managing contract manufacturers
  • Communicate effectively with management and other stakeholders in different functions at various levels
  • Expert at generating and maintaining organized and accurate records and reports
  • Demonstrated skills in lean manufacturing or six sigma
  • Knowledge of EO sterilization
  • Demonstrated knowledge in FDA QSR and ISO regulations
  • The company will not pursue or support visa sponsorship for this position. 

Click HERE to Apply 

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