Director of Engineering - Amico Clinical Solutions

Director of Engineering – Amico Clinical Solutions
Richmond Hill, ON

Are you a dynamic and motivated individual with a passion for being on the leading edge of design and engineering? If so, Amico Clinical Solutions is the right place for you!

We are seeking a Director of Engineering who will lead a team of professional-level mechanical engineers and designers to create state of the art products. You would be responsible for:

• Setting goals and objectives for team members in alignment with organization objectives.
• Support new product development, product improvements and manufacturing.
• Collaborate and maintain a high level of communication with cross-functional team members such as sales, purchasing, project team, production, and quality assurance, to ensure alignment on project scope, design control documentation, quality, and scheduling.
• Collaborate with internal resources to develop technical solutions to difficult problems that are thorough, practical, and consistent with organization objectives. These are often documented on Corrective Action and Preventive Action (CAPA) reports.
• Lead design control procedures to ensure they meet current regulatory requirements and provide a clear and efficient product design process.
• Establish and modernize the engineering process and tools that are used by the team to optimize engineering performance in the context of business needs.
• Monitor documentation maintenance throughout all phases of design.
• Provide training, coaching and mentorship to team members. 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.
• Select, develop and evaluate personnel to ensure the efficiency of team.
• Assist in with any other duties as required by the President.

• Ability to handle and troubleshoot difficult and typically not complex problems.
• Possess a broad range of medical device design and development skills and experience.
• A record of leading teams from product concept through validation and into manufacturing.
• Strong oral and written communication skills.
• Play a key role in mentoring less experienced employees.
• Self-motivated and excited by the prospect of working in a dynamic, entrepreneurial environment.
• Strong organizational and leadership skills.
• Strong data analysis skills, and proficient in the use of statistical tools in problem solving.
• Possesses strong communication skills (verbal & written).

• Bachelor's degree in mechanical engineering or equivalent.
• Minimum 5 years professional experience in medical device product design and development.
• Minimum 3 years 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 the following standards in the work experience – FDA, HC and ISO 13485 Quality System Regulations, Design Controls, Good Manufacturing Practices, ISO 14971, IEC60601.
• Proficient in SolidWorks (Part, Assembly, Sheet Metal & Simulation).
• Strong computer skills (MS Outlook, Word, Excel & MS Project).
• Experience or working knowledge in fabrication/machining tools.