Director of Engineering

3 hours ago


Richmond Hill, Ontario, Canada Amico Group of Companies Full time
Director of Engineering

Amico Clinical Solutions is seeking a highly skilled and experienced Director of Engineering to lead our team of professional-level mechanical engineers and designers. As a key member of our leadership team, you will be responsible for creating state-of-the-art products that meet the highest standards of quality and innovation.

Key Responsibilities:
  • Lead a team of engineers and designers to develop and implement design control procedures that meet current regulatory requirements.
  • Collaborate with cross-functional teams to ensure alignment on project scope, design control documentation, quality, and scheduling.
  • Develop technical solutions to difficult problems that are thorough, practical, and consistent with organization objectives.
  • Establish and modernize the engineering process and tools to optimize engineering performance in the context of business needs.
  • Provide training, coaching, and mentorship to team members to ensure they are familiar with and follow all quality system procedures related to their job.
Requirements:
  • Bachelor's degree in mechanical engineering or equivalent.
  • Minimum 5 years of professional experience in medical device product design and development.
  • Minimum 3 years of management experience with direct reports.
  • Experience with design of medical devices and working within an ISO quality management system.
  • Deep knowledge and application of FDA, HC, and ISO 13485 Quality System Regulations, Design Controls, Good Manufacturing Practices, ISO 14971, and IEC60601 standards.
  • Proficient in SolidWorks and strong computer skills.


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