Boston Scientific Senior Design Assurance Manager- Structural Heart 

United States, Minnesota, Maple Grove 

15130637

Your responsibilities will include:

• Leads quality team on product 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 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.

Required qualifications:

• Bachelor's degree and 7+ years of related work experience or an equivalent combination of education and work experience
• 5+ years of direct or indirect supervisory experience with a passion for leadership and team development
• Medical Device or regulated industry experience

Preferred qualifications:

• Advanced degree in technical field or business
• Experience leading technical teams
• Prior R&D experience
• Regulatory compliance experience in the areas of medical devices, combination products, pharmaceuticals, and analytical methodology
• Experience in structural heart valves

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.