Support the development and refinement of standard operating procedures, with close connection to the product design and development process to comply with applicable quality management systems, standards and regulatory guidance.

  • Make sure that your strategy coordinates/schedules service (self, vendor and, when appropriate, other technicians) via management of customer expectations.
  • Contribute during all phases of the product development cycle with particular emphasis on human factors engineering and usability assessment.
  • Lead activities to ensure design and process shortcomings are identified and appropriately addressed.
  • Lead process sustaining, improvement, design, development in the making of consumable products.
  • Meet health and human services, environment health and safety and/or all other applicable regulatory requirements.
  • Be accountable for supporting the biomedical research and development team in providing technical oversight to its projects.
  • Support stakeholders with financial analysis, project management, reporting, and measuring of data/statistics.
  • Meet health and human services, environment health and safety requirements, and/or all other applicable regulatory requirements.
  • Support analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations.
  • Manage work with the Quality Engineering team on projects to improve product quality and process efficiency throughout the plant.
  • Identify and report any and all customer quality or compliance concerns immediately to the Quality Organization.
  • Support the development and refinement of standard operating procedures related to human factors engineering, with close connection to the product design and development process and quality management systems.
  • Meet health and human services, environment health and safety requirements, and all other applicable regulatory requirements.
  • Arrange that your group advises on specifications for purchases on new equipment and recommends replacement of obsolete or irreparable equipment.
  • Engage others, promote, and lead Environmental, Health, and Safety initiatives, focusing on continuous improvement.
  • Follow department policies, procedures, managerial guidance and good judgment in decision making process.
  • Secure that your project
  • Be accountable for using data indicators, intuition, and/or other resources, identifies system, safety and quality problems, suggests solutions, and provides information that leads to change in department and on teams.
  • Capture feedback and insight about standard of care techniques and competitive products being used in the market.
  • Lead continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible.
  • Coordinate research projects and manage the timing of multiple concurrent projects using project management skills and teamwork.
  • Ensure all design activities conform to design controls; and that all analysis, design and testing activities are properly documented.
  • Manage capacity and efficiency through process improvements and the fabrication, purchase, and qualification of new equipment.
  • Be accountable for using data indicators, intuition, and/or other resources, helps to identify system, safety and quality problems, suggests solutions, and provides information that leads to change in department and on teams.
  • Make sure that your enterprise responds to service calls to evaluate, diagnose, and perform repair and planned maintenance (PM) on complex customers biomedical equipment.

 

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