Senior Design Assurance Manager, Structural Heart

6 days ago

Maple Grove, United States Boston Scientific Full time

Work mode: Hybrid

Onsite Location(s):

Maple Grove, MN, US, 55311

Additional Location(s): N/A


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance


At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

Boston Scientific is recruiting for a Senior Design Assurance Manager at our Maple Grove, MN location. This exciting role involves leading a team within the Structural Heart Valve franchise, focusing on developing and sustaining single-use devices for TAVR, as well as supporting HCP training and clinical therapy development for the portfolio. The role is hybrid with the expectation to be on-site three days a week.

The Senior Design Assurance Manager will provide leadership in design assurance and oversee a team of skilled engineers. The role is responsible for ensuring product quality and compliance by applying Design Control and Risk Management processes. This position is a key partner to the Research & Development, Medical, Regulatory, Marketing, and Manufacturing Engineering teams, contributing to new product development, commercialization, and product sustainment within the rapidly growing Interventional Cardiology (IC) division of Boston Scientific.

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

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