Senior Mechanical Engineer

2 weeks ago

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

FLSA Status
Non-Exempt

Position Summary

The Senior Mechanical Engineer will possess a comprehensive understanding and demonstrate proficiency in executing all tasks related to device service operations. This includes responsibilities such as repair, refurbishment, analysis of out-of-box failures, yield enhancement, and conducting Product Complaint Investigations (PCI).

This role entails leading and coordinating all facets of the service process for devices, encompassing PCI analysis, investigation of device history, and conducting thorough root cause analyses as necessary.


Additionally, this position requires meticulous documentation of all aspects related to device PCI, repair activities, and tracking of labor and materials used.

The individual must be well-versed in the device tracking system (Oracle) to ensure accurate documentation of repairs, resolution of complaints, and the integrity of technical results, ensuring that all analysis and repair activities are recorded correctly.


Essential Duties & Responsibilities

  • Provide leadership in the service and repair of mechanical products, coordinating and prioritizing team activities in alignment with management directives.
  • Participate in daily service meetings to communicate updates and progress.
  • Deliver clear written and verbal updates throughout the day regarding high-priority service activities in collaboration with warehouse, planning, and engineering teams.
  • Guide service staff on shifting priorities and balance workloads based on service demands.
  • Engage in hiring and promotion decisions for the service team.
  • Oversee workflow, line layout, and Lean Six Sigma initiatives within the service area, aiming for continuous improvement of key performance indicators (KPIs) and maintaining an organized and efficient repair environment.
  • Analyze and troubleshoot customer device returns to identify root cause issues.
  • Adhere to all quality and operational procedures within their area of responsibility to comply with applicable Quality System Regulations (e.g., cGMP compliance).
  • Conduct Level 2 and Level 3 PCI investigations, collaborating with Engineering, Quality Assurance, Customer Service, and Global Complaint Management teams as needed.
  • Assist with engineering studies, out-of-box failure analyses, and yield improvement initiatives.
  • May perform troubleshooting and repair of devices at customer locations as required.
  • Collaborate with management and Quality Assurance to identify and rectify process and product non-conformities.
  • Manage and conduct training sessions for service repair and complaint investigation processes.
  • Participate in special projects as they arise.
Knowledge, Skills & Qualifications

  • Ability to lead by example and effectively influence and train team members.
  • Actively support the repair team through strong communication skills, a positive attitude, dedication, and mutual respect.
  • In-depth knowledge of cGMP, processes, and products.
  • Exceptional verbal and written communication abilities.
  • Proficient in writing and editing process documentation.
  • Strong analytical thinking and problem-solving capabilities.
  • Focused on quality and results.
Education and Experience

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

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

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

  • Job responsibilities are carried out in a service repair hub environment.
  • Requires a high level of hand-eye coordination and manual dexterity to work with electro-mechanical medical devices.
  • Must be capable of lifting and moving objects weighing up to 30-40 lbs.

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