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Senior Engineer Design Assurance Job

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Date: Jan 10, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Location: Maple Grove, Minnesota (US-MN), United States (US)
Additional Locations:
Hiring Manager: Johanna F Meier
Recruiter: Susan Vern Seward

 

 

About the Senior Design Assurance role:

Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provides focused quality engineering support within Interventional Cardiology to ensure the ongoing delivery of the highest quality product to the customer.

 

 Your responsibilities:

  • Apply sound, systematic problem-solving methodologies using defined business systems (CAPA) to identify, prioritize, communicate, and resolve quality issues
  • Act as an effective leader in supporting quality disciplines, decisions, and practices
  • Execute in streamlined business systems to effectively identify and resolve quality issues
  • Lead cross-functional field assessments of recently launched medical devices against established risk documentation
  • Influence a cross-functional team to identify and implement effective controls and support changes to commercialized products to meet or exceed internal and external requirements
  • Plan and lead the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements
  • Partner cross-functionally to identify and lead value improvement efforts to support business goals
  • Support post market surveillance of products through competent authority communication
  • Update and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
  • Support medical device audits from internal or external authorities

 

What we’re looking for:

Minimum Qualifications: 

  • Bachelor or Master of Science degree in engineering related field
  • 5+ years of Medical Device Engineer related work experience
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

 

Preferred Qualifications:

  • Problem solver with the knowledge of problem solving tools, capable of facilitating the problem-solving process in a highly regulated work environment
  • Adaptable and effective leader in a team environment or in self-directed work
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on and solution driven approach to problem solving

 

 

 

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: 440532

 


Nearest Major Market: Minneapolis

Job Segment: Engineer, Design Engineer, CAPA, Medical, Risk Management, Engineering, Management, Healthcare, Finance