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Global Standards, R&D Fellow

Work mode:  Hybrid
Onsite Location(s): 

Arden Hills, MN, US, 55112

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:

Our Global R&D team has an exciting opportunity for a Global R&D Standards Coordinator supporting all BSC divisions and franchises. In this role, you will serve as a focal point for all aspects of the utilization of external standards (e.g. ISO, IEC, AAMI, CEN/CENELEC, etc). This is a diverse role concerned with the entire lifecycle of external standards with high visibility across our entire organization.

 
Your responsibilities will include:

  • Chairs the BSC External Standards Council
  • Serves as Product Owner for the company’s standards management application platform
  • Assists in strategic planning for the company in the utilization of external standards.
  • Identifies and evaluates new strategies for management of external standards utilization
  • Establishes relationships with External Standards Organizations and participates in global standards development and advocacy.
  • Meets with global thought leaders in development and use of external standards.  Studies & understands relevant published articles & works for application to company projects and initiatives.
  • Leads education efforts and mentoring in utilization of external standards.
  • Fields requests from R&D teams to make decisions of standards applicability, interpretations, and related regulatory risk factors.
  • Performs technical consultative function and internal company perspective to all divisions within the company.
  • Represents BSC positions in National and International Standards Development Organizations
  • Oversees standards document subscriptions and content

 

Required qualifications:

  • 7+ years of experience with B.S., 5-7 years of experience with M.S.
  • Degree in Engineering in a field related to medical device standards
  • 3+ years of experience as a member of one or more international technical committees developing standards in the medical device space
  • Demonstrated strong cross-functional collaboration, influence without authority, and project/task management enabling highly effective teams 
  • Strong passion for development and use of external standards
  • Strong written and oral communication skills
  • Ability to work independently to plan and schedule own activities necessary to meet timelines

Preferred qualifications:

  • 3+ years experience as a chair or convenor of ISO, IEC, or AAMI committee or working group with successful publication of one or more new or revised standards
  • Deep knowledge of the ISO/IEC directives, AAMI policies
  • Full understanding of standards recognition and harmonization schema in EU, US, and national geographies
  • Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
  • Prior experience in database and UI design to support ongoing enhancement to internal standards application platform
  • Known as a standards “guru” in previous position(s)

 

Requisition ID: 581994

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.  


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 prohibited substance 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.

 

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.


Nearest Major Market: Minneapolis

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