Job Responsibilities:
Lead/support medical device development projects, with input on the engineering, regulatory, and manufacturing aspects of product realization.

Employ design control knowledge to implement medical device changes and improvements.

Take a hands-on approach to product development, managing internal development, external suppliers, and cross-functional groups.

Lead/support product development projects to facilitate achievement of product commercialization objectives and overall business objectives.

Deliver project results and documentation needed to maintain health and enhance existing products to ensure revenue continuity.

Support development of new line-extension product offerings, new or adapted claims and deliver cost-efficient product outputs/solutions.

Utilize risk-based critical thinking to assure compliance with design control process and associated quality/regulatory requirements.

Drive utilization, enhancement and efficiency of scaled controlled design process using continuous improvement approach.


Position Requirements:
• Good comprehension and application of medical device product development, design control and risk management principles
• Demonstrated understanding of applicable US, Canadian regulations and compliance for medical devices
• Excellent communication skills with the ability to interact and influence at all levels internally and externally with suppliers and customers, both verbally and in writing
• Demonstrated continuous improvement mindset, with a strong ability to improve and simplify processes, remove redundancies and non-value-added activities, while respecting regulatory requirements and meeting customer needs
• Business acumen and flexibility and creativity with a solutions-oriented approach to meet business needs while simultaneously delivering compliant solutions
• Excellent analytical, organizational and technical writing skills
• Personal leadership qualities