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Senior Manager, Design Assurance Job

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Date: Jan 13, 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.


Senior Design Assurance Manager

Our Senior Design Assurance Manager will lead a team of Quality Engineers and Technicians in direct support of novel and innovative medical device technology and product development; responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management in the development process, and is a key partner to the Research & Development, Regulatory, Marketing  and Manufacturing Engineering teams in achieving new product development and commercialization. Quality Team lead for all quality functions that contribute to the product development process and is responsible to provide a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance. Owns and manages quality discrepancies during the design and development process, and develops scope, disposition, and corrective actions for prevention of future discrepancies. Monitors field performance of commercial product, subsequent investigations and actions.  May serve as liaison between the company and the various governmental agencies worldwide. 


Your responsibilities will include:

  • Leads quality team on product development projects of major magnitude and scope.
  • 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.
  • 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 control the activities and budget of one or more functional areas, divisions, product groups, projects/programs, and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).


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.
  • Technical background, 4-year engineering degree preferred with a passion for technology development and continuous improvement.
  • Medical Device or regulated industry experience.


Preferred qualifications:

  • Experience leading technical teams
  • 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: 472854


Nearest Major Market: Minneapolis

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