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Senior Engineer Design Assurance Job

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Date: Dec 7, 2018

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

We have an exciting opportunity for a Senior Design Assurance Engineer supporting Structural Heart projects within the Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential.  Work with high-performance cross-functional development team to establish and maintain the design control and risk analysis required to bring novel technologies into clinical trials and commercialization.   

 

 Your responsibilities include:

  • Actively promote and participate in a cross-functional teamwork environment.
  • Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Lead/support implementation of reliability program for device implant and materials.
  • Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables

 

What we’re looking for:

Minimum Qualifications

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
  • 3-5+ years of experience in design assurance, new product development or related medical device experience
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on approach to product development
  • 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

  • Previous development of surgical or transcatheter valve or other complex medical device system experience.
  • Experience with technology acquisition & integration
  • Experience interfacing with physicians to gather insight into new product concepts and associated risk.

The Design Assurance Senior Engineer position supports a major product category with high visibility which will provide the right candidate with excellent growth potential.  Work with high-performance cross-functional development team to establish and maintain the design control and risk analysis required to bring novel technologies into clinical trials and commercialization.   

 

 Your responsibilities include:

  • Actively promote and participate in a cross-functional teamwork environment.
  • Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables

 

 Minimum Qualifications

  • Bachelor’s degree in an Engineering discipline or related field of study
  • 3-5+ years of experience in design assurance, new product development or related medical device experience
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on approach to product development
  • 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

  • Previous development of complex medical device system experience.
  • Experience with technology acquisition & integration
  • Experience interfacing with physicians to gather insight into new product concepts and associated risk.
  • Previous experience with developing capital equipment as a medical device

 

 

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: 434748

 


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