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Engineer I, Hardware Design Assurance Job

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Date: Dec 1, 2018

Location: Fremont, CA, US, 94538

Company: Boston Scientific

Additional Locations: US-MN-Maple Grove



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.


Hardware Design Assurance (DA) Engineer I


Purpose Statement

Applies quality engineering methodologies during the development and lifecycle management of medical electrical equipment.  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

General Summary

Provides focused quality engineering support on new product development and sustaining engineering activities. 

Design Assurance drives the ISO 14971 risk management process, usability engineering activities, and the design verification & validation (V&V) processes.  This includes risk management plans and reports, hazard analysis, failure modes and effects analysis (FMEA), device use task analysis, formative and summative usability study protocols and reports, review and traceability of marketing and design specifications, test method development and validation, sampling methods and statistical techniques, verification protocols/tests/reports, and validation protocols/tests/reports. 

Interfaces with other quality and engineering teams within the company and with customers and suppliers on quality-related issues.

Key Responsibilities

  • Develop and execute design verification and validation test protocols.
  • Maintain documentation of test results.
  • Support risk management and usability activities.
  • Analyzes test results to ensure existing functionality and recommends corrective actions.
  • Participates in product failure investigation and root cause analysis.
  • Other duties as assigned or requested.

 Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 Basic Qualifications:

  • Minimum BS Electrical Engineering or related technical degree and 0-1 years of relevant industry experience
  • Ability to develop and execute test cases with moderate oversight
  • Experience solving problems of moderate scope and complexity
  • Good written and verbal communication skills

Preferred Qualifications:

  • Cross-functional team membership
  • Experience working in a regulated environment
  • Knowledge of reliability methodologies
  • Knowledge of electrical safety standards IEC 60601, risk management standards ISO 14971, and usability standards IEC 62366



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: 431166


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Job Segment: Medical, Engineer, Electrical, Product Development, Hardware Engineer, Healthcare, Engineering, Research