Director of Engineering

3 hours ago

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

Director of Engineering – Amico Clinical Solutions
Richmond Hill, ON

We are seeking a seasoned engineering professional to lead our team of mechanical engineers and designers in creating innovative medical devices. As Director of Engineering, you will be responsible for:

  • Setting goals and objectives for team members in alignment with organizational objectives.
  • Supporting new product development, product improvements, and manufacturing.
  • Collaborating with cross-functional teams to ensure alignment on project scope, design control documentation, quality, and scheduling.
  • Developing technical solutions to complex problems, often documented on Corrective Action and Preventive Action (CAPA) reports.
  • Leading design control procedures to ensure compliance with current regulatory requirements and a clear, efficient product design process.
  • Establishing and modernizing the engineering process and tools to optimize engineering performance.
  • Monitoring documentation maintenance throughout all phases of design.
  • Providing training, coaching, and mentorship to team members, driving a culture of creativity, innovation, and continuous learning.
  • Ensuring direct reports are familiar with, trained on, and follow all quality system procedures related to their job.
  • Selecting, developing, and evaluating personnel to ensure team efficiency.

Core Competencies

  • Ability to handle and troubleshoot complex problems.
  • Broad range of medical device design and development skills and experience.
  • Record of leading teams from product concept through validation and into manufacturing.
  • Strong oral and written communication skills.
  • Mentorship and leadership skills.
  • Self-motivation and enthusiasm for working in a dynamic environment.
  • Strong organizational and leadership skills.
  • Strong data analysis skills and proficiency in statistical tools.

Experience/Education

  • 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 an asset.
  • Experience working within an ISO quality management system.
  • Experience leading product development from requirements to final release/launch.
  • 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 MS Office.

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