Senior Design Assurance Manager - Interventional Cardiology and Vascular Therapy
About The Position
Leads quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects. Leads quality team on functional deliverables and ensures technical excellence for product or technical development. Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives. Including leading V&V activities and failure investigations. Owns and drives commercial product monitoring and all related product sustainment activities. Develops and implements quality strategies; seeks innovative approaches to attaining quality goals. Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff. Develops department budget and monitors spending. Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly. Maintains and enhances cross-functional team relationships. Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues. Lead a team of employees in the achievement of organizational goals. Coach, direct, and develop a high performing team. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Directly interfaces with internal and external audit activities.
Requirements
- Minimum of a Bachelor's degree
- Minimum of 7 years of related work experience or an equivalent combination of education and work experience
- Minimum of 5 years of direct or indirect management experience with a passion for leadership and team development
- Medical Device or regulated industry experience
Nice To Haves
- Advanced degree in technical field or business
- Experience leading technical teams
- Regulatory compliance experience in the areas of medical devices
- Understanding of applicable electrical safety standards and configuration management (e.g IEC 60601, 62304)
- Experience working in global environment (e.g. Costa Rica, APAC, Ireland)
Responsibilities
- Lead quality team on product/system development projects
- Own and drive deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance
- Lead V&V activities and failure investigations
- Own and drive commercial product monitoring and all related product sustainment activities
- Develop and implement quality strategies
- Provide guidance and training to staff
- Develop department budget and monitors spending
- Determine appropriate staff levels and schedules
- Maintain and enhance cross-functional team relationships
- Provide significant guidance regarding technical strategies and approaches
- Lead a team of employees in the achievement of organizational goals
- Coach, direct, and develop a high performing team
- Foster a diverse workplace
- Monitor and ensure compliance with company policies and procedures
- Directly interfaces with internal and external audit activities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
