Senior Manufacturing Engineer

StrykerCary, IL
$85,500 - $142,500Onsite

About The Position

Join a manufacturing engineering team that supports the production of medical device, drug, and cosmetic products in a highly automated, regulated manufacturing environment. This role provides technical leadership for manufacturing processes and equipment, with a focus on supporting automation systems, validating new equipment, and driving operational performance in a world-class production facility.

Requirements

  • Bachelor’s degree in Engineering or a related technical field.
  • Minimum 2 years of full-time experience in manufacturing engineering, mechanical engineering, or a related engineering discipline.
  • Minimum 2 years of experience supporting manufacturing operations and production equipment.
  • Experience troubleshooting automated manufacturing equipment.
  • Experience implementing process improvements in a manufacturing environment.

Nice To Haves

  • Bachelor’s degree in Mechanical, Electrical, Controls, Industrial, Biomedical, or Manufacturing Engineering.
  • Minimum 2 years of experience in the medical device industry.
  • Experience writing, executing, and documenting process or equipment validations, including IQ, OQ, PQ, or related protocols.

Responsibilities

  • Support factory acceptance testing (FAT), equipment installation, commissioning, and startup activities for new manufacturing equipment and automation systems.
  • Develop and maintain process Failure Mode and Effects Analyses (FMEAs), control plans, and other process documentation for new and existing production lines.
  • Execute and document process validation activities, including Validation Plans (VP), User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Create and maintain standard operating procedures (SOPs), work instructions, and technical documentation in compliance with Good Manufacturing Practices (GMP).
  • Monitor production line performance, investigate equipment and process issues, and lead structured problem-solving initiatives to improve reliability, efficiency, and quality.
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