Create high quality deliverables using appropriate business and technical language, especially developing and reviewing audit programs or testing steps, adapting an audit program to suit a clients specific environment, and/or Design Controls evaluations and testing work plans.

More Uses of the Design Control Toolkit:

  • Secure that your organization develops and applies computer aided design (CAD) software engineering methods, theories and research techniques in the investigation and solution of technical problems.
  • Formulate the medium term regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying and executing organization regulatory strategies and policies that affect immediate operations.
  • Establish that your business translates customer and business strategies into engineering design concepts and drive efficient product development with modern Design Control processes.
  • Support post market surveillance processes through the analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.
  • Ensure you engineer; build relationships with technical and compliance teams to deliver privacy by Design Controls that are incorporated into security architecture, infrastructure, and code.
  • Provide quality assurance expertise and guidance for new product development/Design Control, risk management, manufacturing, supplier qualification, material qualification, and product quality.
  • Ensure you persuade; lead system level root cause investigations, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
  • Perform product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, hazard analysis, product test and evaluation, System V and V, and/or Design Control documentation.
  • Execute packaging development activities in alignment with the elements of Design Controls, and ensure that all packaging materials/systems comply with departmental and applicable regulatory requirements.
  • Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
  • Provide technical guidance and support based on overall project plans with the development of products in compliance with Design Controls, processes in compliance with Good Manufacturing Practices (cGMP).
  • Be certain that your operation supports design assurance quality engineers with product improvement through implementation of quality management policies, procedures, specifications, test methods and measurement systems.
  • Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports.
  • Collaborate closely with cross functional team members mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines to design iterations to quickly and effectively develop effective user interfaces.
  • Manage work with systems engineering and other cross disciplinary engineering functions to support development of test cases and protocols for design verification.
  • Evaluate the design feasibility of new product ideas and use Design Control processes to develop new product designs from concept to commercialization.
  • Manage: creative and innovative thinking to resolve issues and overcome obstacles, using sound judgment and structured methods to effectively analyze options, risks and implications.
  • Secure that your team contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
  • Direct: work is expected to result in significant contributions to the development of new or refined equipment, materials, processes, products, and/or methods.
  • Make sure that your team adheres to stated policies and procedures relating to health and safety, and quality management in support of your organizations SOPs and best practices.
  • Confirm your planning ensures compliance with quality and regulatory requirements by applying Design Control processes as risk management, configuration management, requirements management and verification testing.
  • Determine feasibility of designing equipment or modifying existing equipment considering costs, time limitations, organization planning, and other technical and economic factors.
  • Manage: complete planning and execution of Design Controls, risk management, test method development and validation, design verification/validation for new and existing products.
  • Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
  • Secure that your business represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
  • Standardize: actively engage and support the device development engineering core team to ensure the combination product and engineering execution against the established requirements.
  • Provide technical support based on overall project plans with the development of products in compliance with Design Controls and processes in compliance with Good Manufacturing Practices (GMP).
  • Supervise: confident when interacting with various levels of management, stays focused and on point, and can raise problems or challenges in a productive manner.
  • Perform requirements engineering management, ensuring requirements are structured, organized, maintained, and communicated across multi disciplined and multi site teams.
  • Methodize: actively lead the interactions with the contract manufacturer and suppliers as IT related to quality and provide support in the resolution of quality problems.

 

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