Manufacturing Validation Specialist

2 weeks ago


Irvine, California, United States SysMind Tech Full time
Job Title: Manufacturing Validation Engineer

We are seeking a highly skilled Manufacturing Validation Engineer to join our team at SysMind Tech. As a key member of our team, you will be responsible for ensuring the quality and reliability of our manufacturing processes.

Key Responsibilities:
  • Train mechanics and operators on internal processes and equipment requirements
  • Perform Installation Qualification, Operational Qualification, and Process Qualification
  • Develop validation protocols, qualify first articles, and complete process capability studies and process validation
  • Prepare reports as per project requirements
  • Actively participate in setting overall project objectives and direction
  • Work with R&D to support process development, process improvements, and process transfer activities
Requirements:
  • 4+ years of experience in manufacturing validation and technical support
  • Demonstrated proficiency in manufacturing validation and providing ongoing technical support
  • Knowledge of Medical Equipment manufacturing processes, GMP, and ISO 9000
  • Ability to specify and qualify Assembly, Tooling, Gage equipment, and Fixture equipment
  • Knowledge of Process validation, Statistical process control, Product design, and DFMA
  • Knowledge of biocompatibility in the medical device industry
  • Excellent analytical problem-solving, business planning, and cross-functional integration skills
Preferred Qualifications:
  • Training and experience in Good Manufacturing Practices and ISO 9000
  • Experience in the Medical Device industry
  • Knowledge of Ergonomics and financial analysis skills
  • Excellent interpersonal and communication skills

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Manufacturing Validation Engineer looking for a new challenge, please submit your application.



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