Equipment Engineer

Northridge, CA, US • Posted 8 hours ago • Updated 8 hours ago
Contract W2
12 Months
Travel Required
On-site
$50 - $55/hr
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Fitment

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Job Details

Skills

  • medical device manufacturing
  • equipment validation
  • IQ/OQ/PQ

Summary

Job Description:

  • Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment.
  • Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits.
  • Establish preventive maintenance plans, calibration schedules, and critical spare parts lists.
  • Author validation plans, validation protocols, test reports, including deviations and corrective actions and Standard Operating Procedures (SOPs).
  • Utilize tools such as Minitab to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies.
  • Perform equipment risk assessments, including pFMEA and hazard analysis.
  • Define User Requirements Specifications (URS) for new equipment and lead equipment installation and commissioning efforts.
  • Train technicians and operators on validated equipment procedures.
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
  • Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines to highvolume production.
  • Work with Manufacturing Engineers to improve equipment reliability and throughput.
  • Support internal and external audits by providing equipment validation evidence.
Required Qualifications
  • Bachelor s degree in mechanical, Electrical, Industrial, Biomedical Engineering, or a related field.
  • 3+ years of equipment validation experience within medical device manufacturing.
  • Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements.
  • Familiarity with automated equipment, robotics, PLCs, and machine vision systems.
Preferred Qualifications
  • Prior experience validating equipment for biosensor or electrochemical sensor manufacturing, or experience in the semiconductor industry for wafer production.
  • Experience with highspeed automation and semiautomated production lines.
  • Certification in equipment validation or GAMP 5 training.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91131463
  • Position Id: 9018235
  • Posted 8 hours ago

Company Info

About Saim Technologies

Saim Technologies provides a variety of services related to Information Technology and out sourcing and has been recognized as a one of the emerging leader in software solutions. We provide custom software development, Staffing, Training and engineering services. We offer Enterprise level web based applications, web services, technical resources, Enterprise level database, software hosting, technical support services, routine programming, and more.

Our IT services focus on providing you with increased business performance by leveraging our technological expertise, business knowledge, process quality, and people. Our dedicated Centers of Excellence and practices around each of our service offerings enable us to continuously improve processes, retain project learning, and expand knowledge repositories to deliver consistent value.

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SK

Sujeet Kumar

Recruiter @ Saim Technologies
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