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Mechanical Engineering Senior Specialist

2 months ago


Lake Forest, California, United States ICU Medical Full time
Job Title
Senior Engineer, Mechanical

FLSA Status
Non-Exempt

Position Summary

This role requires a comprehensive understanding and proficiency in executing all tasks essential for device service operations, encompassing repair, refurbishment, failure analysis, yield enhancement, and Product Complaint Investigations (PCI).

Additionally, this position entails overseeing and coordinating all facets of the service process for devices, including PCI analysis, investigation of device history, and thorough root cause analysis as necessary.


This individual will also be tasked with documenting the necessary components of device PCI, repair, and tracking of labor and materials.

Expertise in the device tracking system (Oracle) is crucial to ensure accurate documentation of repairs, resolution of complaints, and that all results are technically precise and encompass required elements, guaranteeing that the analysis and repair activities are properly recorded.


Essential Duties & Responsibilities

  • Provide leadership for the service and repair of products. Coordinate and prioritize team activities and assignments in conjunction with management.
  • Attend daily service meetings and communicate updates effectively.
  • Deliver concise written and verbal updates throughout the day on high-priority service activities.
  • Guide service staff on shifting priorities and balance workload as needed based on service requirements.
  • Participate in hiring and promotion decisions for the service line.
  • Manage workflow, line layout, and Lean and 6S activities for service, aiming to continuously improve KPIs and maintain an organized and efficient repair area.
  • Troubleshoot and analyze customer device returns to identify root cause issues.
  • Adhere to all quality and operational procedures to meet applicable Quality System Regulations.
  • Conduct Level 2 and Level 3 PCI investigations, collaborating with Engineering, QA, Customer Service, and Global Complaint Management teams as necessary.
  • Assist with notebook/engineering studies, out-of-box failure analysis, and yield improvement activities.
  • May perform troubleshooting and repair of devices at customer locations.
  • Collaborate with management and QA to identify and resolve process and product non-conformities.
  • Manage and conduct training activities for service repair and complaint investigation processes.
  • Engage in special projects as they arise.
Knowledge, Skills & Qualifications

  • Must lead by example and influence and train others effectively.
  • Actively support the repair team through solid communication skills, dedication, and respect.
  • Strong knowledge of cGMP, processes, and products.
  • Excellent verbal and written communication abilities.
  • Proficient in writing and editing process documentation.
  • Proven analytical thinking and problem-solving capabilities.
  • Quality and results-oriented mindset.
Education and Experience

  • High School diploma or GED equivalent.
  • Associate degree in a technical discipline from an accredited institution is preferred or equivalent experience.
  • Minimum of 7-10 years of industry experience in a high-tech manufacturing environment.
Minimum Qualifications

  • Must be at least 18 years of age.
  • Must pass pre-employment drug screening and background check.
Travel Requirements

  • Typically requires travel less than 25% of the time.
Physical Requirements and Work Environment

  • Job duties are performed in a service repair hub environment.
  • High level of hand-eye coordination and manual dexterity is required to work with electro-mechanical medical devices.
  • Must be able to move and lift objects weighing up to 30-40 lbs.