Manager, Engineering System Operations

Job ID 21000JGD

Available Openings 1

Position Available

Manager, Engineering Systems Operations, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Concord, CA

Responsible for creating an efficient product development system and processes to provide the R&D teams the tools and guidance required for enhanced product performance with shorter product development time.

Specific responsibilities and duties will include:
  • Providing product development expertise from a process, method, and tools perspective in the early stages of product development.
  • Leading operational efforts, constructing strong frameworks of knowledge and processes with the intent of building robust Design Control system.
  • Building an Engineering System Operations function supporting capability deployment and operation across the organization including talent acquisition, staff development, retention, and budget.
  • Providing direct support for product development processes, quality management system, design control and quality engineering.
  • Ensuring consistent implementation of tools & methodologies while adhering to quality and compliance requirements; interfacing with design assurance and regulatory groups as needed.
  • Driving usage ("run mode") of engineering capabilities specifically to the product / development project by keeping centrally global definition in focus and pro-actively addressing configuration management, analytics on product data, and dependencies with Quality Management System.
  • Capturing feedback and identify additional needs from product team / development project for improvements, enhancements, deficiencies, and pain points with engineering capabilities.


This position will be responsible for the supervision of three (3) individuals, each working in the Senior Engineer, Engineering Systems Operations position.

Requirements:

This position requires a Bachelor's degree or foreign equivalent in Biotechnology, Microbiology, Biomedical Engineering, Chemical Engineering or a closely related field and five (5) years of experience in medical device quality management. Alternatively, will accept a Master's degree or foreign equivalent in Biotechnology, Microbiology, Biomedical Engineering, Chemical Engineering or a closely related field and three (3) years of experience in medical device quality management.

Experience, which may have been gained concurrently with the primary experience requirement above must include three (3) years of experience in the following:
  • Managing the quality function, including assuring reliability targets and testing are appropriately implemented, suitable quality tools are deployed and utilized on projects, the appropriate level of design verification and validation activities are performed, and project schedules are met.
  • Leading the implementation of quality standards (assurances, process controls, change control, and CAPA systems) designed to meet requirements
  • Preparing technical reports, standards, and specifications to ensure regulatory requirements compliance for design verification and validation
  • Creating design verification and validation protocols and reports


This position requires 10% domestic and international travel.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.