Director of Engineering
4 weeks ago
Director of Engineering – Amico Clinical Solutions
Richmond Hill, ON
We are 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 organization, you will be responsible for driving the development of state-of-the-art products and ensuring that our engineering processes meet the highest standards.
Key Responsibilities:
- Develop and implement engineering strategies to drive business growth and improve product quality.
- Lead a team of engineers and designers to design, develop, and test new products and product improvements.
- Collaborate with cross-functional teams to ensure alignment on project scope, design control documentation, quality, and scheduling.
- Develop and maintain technical solutions to complex problems, including documentation on Corrective Action and Preventive Action (CAPA) reports.
- Establish and modernize the engineering process and tools to optimize engineering performance.
- Monitor documentation maintenance throughout all phases of design.
- Provide training, coaching, and mentorship to team members to drive a culture of creativity, innovation, and continuous learning.
- Ensure that all direct reports are familiar with, trained on, and follow all quality system procedures related to their job.
- Assist in selecting, developing, and evaluating personnel to ensure the efficiency of the team.
Core Competencies:
- Ability to handle and troubleshoot complex problems.
- Strong technical skills in medical device design and development.
- Proven track record of leading teams from product concept through validation and into manufacturing.
- Excellent oral and written communication skills.
- 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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