Sustaining Engineer

23 hours ago


Thousand Oaks, United States Planet Pharma Full time

12 Month Contract (May extend or convert to permanent)

$38/hour W2


Must Have Requirements:

  • Degree in Engineering or Computing Field.
  • Medical Device Industry experience and regulated work environment experience.
  • Strong understanding and experience in design controls, failure investigation (leading an investigation).
  • Ability to clearly communicate with diverse teams, including Engineering, Manufacturing, Regulatory, and Quality colleagues.
  • Strong written skills for documenting changes, updates to risk files, and communication with leadership.
  • Multidisciplinary assessment of complaints and problem-solving.
  • Knowledge of CAPA processes and GDP.
  • Familiarity with Excel for data analysis.


Day to Day Responsibilities:

  • Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
  • Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
  • Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
  • Establish experimental protocols, conduct experiments, analyze results
  • Support technical execution of Design History File (DHF) updates
  • Establish and maintain relationships with Manufactuing site colleagues
  • Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
  • Establish and review specifications/requirements for components, products and processes
  • Support CAPA investigations
  • Ensures product conforms to current relevant international standards
  • Support multi-functional assessment of complaint record


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