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Sr Design Assurance Quality Manager - New Product Development Job

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Date: Apr 5, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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:

We have an exciting opportunity for a Sr. DA Manager to support our Peripheral Interventions (PI) division in Maple Grove, MN.

 

Key responsibilities include:

  • Driving functional excellence in Design Assurance by providing coaching and mentoring on product design development best practices, including Risk Management and Design Controls to assure technical excellence.
  • Provides guidance and approval regarding quality strategies and approaches.
  • Hiring, guiding, training and developing world-class staff to provide technical leadership for multiple NPD projects. 
  • Working cross-functionally in identifying and resolving technical issues, takes a pro-active role in building bridges across the organization to mitigate issues.
  • Driving and evaluating project and department progress, technical development plans, and results. 
  • Provide leadership and guidance to support the Quality initiatives including product performance. 
  • Interface with R&D, PD, OPs and DA Managers to provide prioritization of work for the DA team.
  • Monitors and evaluates project and department progress and results.
  • Lead a group or team of employees in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports, and drive best practices throughout their organization.    
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Direct and control the activities and budget of one or more functional areas and/or projects/programs.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

 

What we’re looking for:

Minimum qualifications:

  • Bachelor's degree and 8+ 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.
  • Proven technical leadership and project management skills in medical device design, development, and commercial launch.  
  • Strong communication skills with a proven ability to be an independent critical thinker, and the ability to build effective cross-functional relationships.
  • Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.
  • Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations. 

 

Preferred qualifications:

  • B.S. Technical Degree such as Mechanical Engineering, Materials Science and/or Biomedical Engineering.
  • Understanding of risk management and design controls tools and requirements for medical device product development.

Requisition ID: 477545

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


Nearest Major Market: Minneapolis

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