Senior Process Engineer

2 months ago

Kitchener, Ontario, Canada KNG Technical Inc. Full time
About KNG Technical Inc.

We are a leading company in the allergy diagnostic market, poised to disrupt the industry with our innovative point-of-care testing system. Our development centre is based in Ontario, Canada, where we are building a talented team of professionals to drive our success.

Job Summary

We are seeking an experienced Senior Process Engineer to join our growing team. As a key member of our multidisciplinary team, you will have the opportunity to contribute to the development and commercialization of our ground-breaking new allergy product.

Responsibilities
  • Manage the transition of R&D assays into an ISO 13485 compliant quality system
  • Coordinate manufacturing activities for commercialization, including collaboratively characterizing manufacturing processes with R&D staff
  • Develop strategic plans for product manufacturing and expanding operations in collaboration with senior management
  • Ensure compliance with FDA QSR and ISO 13485 regulations
  • Develop and maintain standard operating procedures and batch production records
Requirements
  • Bachelor's, master's, or PhD degree in engineering, chemistry, biochemistry, bioengineering, or a related field with experience in process development
  • 5+ years of experience in immunoassay development
  • Demonstrated track record of solving challenging issues with assay design, development, and optimization
  • Excellent organizational and project management capabilities
  • Strong verbal and written communication skills
  • Ability to multitask, manage multiple projects, and rapidly learn new techniques and approaches
  • Ability to work effectively in a cross-disciplinary environment
  • Familiarity with Medical device development and working in FDA QSR and ISO 13485 environments

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