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.

More Uses of the Biomedical Engineering Toolkit:

  • 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.
  • Standardize: review, analyze, and release engineering change orders to coordinate implementation between engineering, quality, and manufacturing groups.
  • 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.
  • Govern: work closely with the technical engineering team in coordinating departmental priorities, budgeting, and evaluating progress toward achieving department objectives.
  • 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.
  • Head: production process and equipment performance quality of support (uptime, improvements, resolving repetitive issues).
  • Follow department policies, procedures, managerial guidance and good judgment in decision making process.
  • Secure that your project applies advanced theories, principles, concepts, and practices of Biomedical Engineering and keeps abreast of changes in technology utilizing that information to meet operational needs.
  • 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.
  • Direct: partner with design teams to develop appropriate production tooling, perform critical design review and procuring tooling and equipment.
  • 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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