Director of Engineering
3 days ago
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 regulatory requirements and a clear product design process.
- Establishing and modernizing engineering processes and tools to optimize 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 quality system procedures.
- 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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