Senior Design Assurance Manager - WATCHMAN
About The Position
Boston Scientific is currently recruiting for a Senior Design Assurance Manager to lead a team of engineers in the Watchman franchise responsible for developing and sustaining implantable and single use devices for use in Left Atrial Appendage Closure. The role will interact with Quality peers in Minnesota, Ireland and Costa Rica. The Senior Design Assurance Manager will provide DA leadership and lead a team of skilled Engineers. This Senior Design Assurance Manager will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management. This Senior Design Assurance Manager will be a key partner to the Research & Development, Medical, Regulatory, Marketing and Manufacturing Engineering teams in achieving new product development, commercialization and product sustainment within Interventional Cardiology (IC), which is a rapidly growing division of BSC.
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 supervisory experience with a passion for leadership and team development
- Medical Device or regulated industry experience.
- Applied experience in test method development, risk management and other design control processes.
Nice To Haves
- Advanced degree in technical field or business
- Experience leading technical teams
- Regulatory compliance experience in the areas of medical devices, combination products, pharmaceuticals, and analytical methodology
- Experience in cardiology applications involving nitinol and catheter-delivery systems.
Responsibilities
- Key Quality voice of influence on sustaining projects and cross functional CAPA product investigations.
- Leads quality team on functional deliverables and ensures technical excellence for product or technical development in the achievement of organizational goals.
- Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance
- Owns and drives commercial product monitoring and all related product sustainment activities.
- Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.
- Driving functional excellence in Design Assurance (DA) by developing, coaching, mentoring, and leadership on product design changes, while ensuring technical excellence.
- Develops department budget and monitors spending.
- 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.
- Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
- Directly interfaces with internal and external audit activities.
Benefits
- Relocation assistance may be available for this position at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
