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Senior Design Assurance Manager- Interventional Cardiology (IC) Job

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Date: Feb 15, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Boston Scientific is currently recruiting for a Sr. Design Assurance Manager to lead a team in our Maple Grove MN location.  This is an exciting opportunity to lead a team in sustaining and developing of medical electrical equipment with specific focus on mechanical and electrical elements.  You will work with your R&D, PD and Manufacturing peers on current and future Interventional Cardiology (IC) products/systems in this rapidly growing division of BSC.

 

This role will provide DA leadership for Hardware and Software development and sustaining for the IC business and lead a team of skilled Engineers and Technicians.  You will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management and is a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving new product development, commercialization and product sustainment.   

 

Your responsibilities include:

  • 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.  

 

What we’re looking for in you:

Minimum qualifications:

  • Bachelor's degree plus 7-9 years of related work experience or an equivalent combination of education and work experience.
  • 5+ years of direct supervisory experience with a passion for leadership and team development.
  • Medical Device or regulated industry experience.
  • Understanding of applicable electrical safety standards and configuration management
  • Experience in reliability testing

Preferred qualifications:

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

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 472853

 


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