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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 demonstration of proficiency in executing all necessary tasks related to device service operations. This includes repair, refurbishment, analysis of out-of-box failures, yield enhancement, and investigations into product complaints (PCI).

Additionally, this position is accountable for overseeing and coordinating all facets of the service process for devices, which encompasses PCI analysis, investigation of device history, and thorough root cause analysis as needed.


Key Responsibilities
  • Lead and manage the service and repair operations for products, ensuring effective coordination and prioritization of team tasks in collaboration with management.
  • Participate in daily service meetings to provide updates and communicate essential information.
  • Deliver clear written and verbal updates throughout the day regarding high-priority service activities, liaising with warehouse, planning, and engineering teams.
  • Guide service personnel on changing priorities and balance workloads as required by service demands.
  • Engage in recruitment and promotion processes for the service team.
  • Oversee workflow, layout, and Lean Six Sigma initiatives for service, aiming to continuously enhance key performance indicators (KPIs) and maintain an organized and efficient repair area.
  • Diagnose and analyze customer device returns to identify root cause issues.
  • Adhere to all quality and operational procedures within the 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 necessary.
  • Assist with notebook/engineering studies, out-of-box failure analyses, and yield improvement efforts.
  • May involve troubleshooting and repairing devices at customer locations.
  • Collaborate with management and quality assurance to identify and rectify process and/or product non-conformities.
  • Manage and conduct training sessions for service repair and complaint investigation processes.
  • Engage in special projects as they arise.
Knowledge, Skills & Qualifications
  • Ability to lead by example and influence and train team members.
  • Actively support the repair team through effective communication, dedication, and respect.
  • Strong knowledge of cGMP, processes, and products.
  • Excellent verbal and written communication skills.
  • Proficient in writing and editing process documentation.
  • Demonstrated analytical thinking and problem-solving abilities.
  • 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 complete 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 functions are performed 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.