Director of Engineering
3 days ago
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.
- Key Responsibilities: Set goals and objectives for team members in alignment with organization objectives. Support new product development, product improvements, and manufacturing.
- Collaborate with cross-functional team members 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.
- 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 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.
Core Competencies:
- Ability to handle and troubleshoot difficult and typically not 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.
- 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.
Experience/Education:
- 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 FDA, HC, and ISO 13485 Quality System Regulations, Design Controls, Good Manufacturing Practices, ISO 14971, IEC60601 standards.
- 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.
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