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Director of Engineering
2 months ago
Amico Clinical Solutions is seeking a highly skilled and experienced Director of Engineering to lead our team of professional-level mechanical engineers and designers in creating state-of-the-art products.
Key Responsibilities:- Collaborate with cross-functional teams 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 used by the team to optimize engineering performance in the context of business needs.
- Provide training, coaching, and mentorship to team members.
- 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.
- Deep knowledge and application of FDA, HC, and ISO 13485 Quality System Regulations, Design Controls, Good Manufacturing Practices, ISO 14971, and IEC60601.
- Proficient in SolidWorks and strong computer skills.