Manufacturing Engineer
Intellijoint Surgical - Waterloo, ON

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Job Overview:

Intellijoint Surgical Inc is a start-up medical device company that develops intelligent surgical tools for precise intra-operative localization in surgical procedures. Intellijoint’s flagship product assists orthopaedic surgeons with precise implant positioning during hip replacement surgery. For more company info, visit www.intellijointsurgical.com

Intellijoint is seeking a Manufacturing Engineer with skills and passion for a dynamic start-up environment. This role is focused on supporting the growth of Intellijoint’s medical device manufacturing operations. Talented individuals meeting the criteria below are encouraged to apply:

Job Duties and Responsibilities:

  • Assist in overall manufacturing operations management and facility infrastructure maintenance
  • Define and perform process and equipment qualifications and validation as necessary (i.e. IQ, OQ, PQ)
  • Manage controlled equipment, calibration requirements and documentation
  • Assist in developing, managing and improving processes for supply chain, production, product flow and RMA product
  • Perform various product-related activities including shipping/receiving, incoming component inspection, and product assembly
  • Assist in managing product inventory, demand planning and forecasting
  • Participate in managing and interfacing with suppliers and contract manufacturers
  • Lead efforts for design transfer from R&D to manufacturing
  • Support ongoing R&D design activities, including product documentation (DHF, DMR, DHR, etc) and verification/validation testing
  • Participate in quality investigations and other duties as necessary in a regulated environment
  • Perform documentation according to Intellijoint procedures and best practices.
  • Other duties as assigned

Required Skills and Experience:

  • 5+ years relevant engineering experience in a regulated manufacturing environment
  • Bachelor’s degree or equivalent in relevant field

Soft Skills:

  • Strong organizational, inter-personal, and communication skills (written and oral)
  • Able to function in a self-directed manner with high degree of independence
  • Ability to plan, prioritize and lead where necessary
  • Able to effectively interface with various company stakeholders (R&D, Operations, QA/RA, Clinical, etc.)
  • Creative problem solver
  • Attention to detail
  • Adaptable to various duties as necessary in a start-up environment
  • Initiative
  • Team player

Nice-to-have:

  • Medical device engineering, manufacturing and/or quality experience preferred
  • Experience working within a medical device environment (ISO 13485, FDA QSR)
  • Experience with transfer to manufacturing activities, supplier management and production planning
  • Experience sourcing and implementing ERP systems
  • Experience in verification and validation and management of external testing partners
  • Experience in project management principles

Job Details:
Full time, based at Intellijoint Surgical’s main office in Waterloo, ON.

How to Apply:
Please submit cover letter and resume for consideration. Only selected applicants will be contacted for an interview. Thank you!


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