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Systems Validation Engineer II Job

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Date: Jun 26, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations:

 

 

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.

 

Job Title: Systems Engineer II

 

About This Role: 

  • To ensure the quality of Boston Scientific Corporation’s software applications and equipment by validating/qualifying to specifications.  Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.

Your Responsibilities Include: 

  • Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
  • Provide project estimates independently.  Review estimates for Engineer I's.
  • Submit specification, protocol and report for approvals and documentation control via a Change Notice
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document and communicate and follow-up on software/equipment issues.
  • Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Create documents, links and Change Notices utilizing a Product Data Management system.
  • Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
  • Develop and review comprehensive validation procedures in compliance with FDA.
  • Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
  • Provide peer reviews on specifications, protocols and reports.
  • Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
  • Provide leadership role on championing functional best practices.

What We're Looking For:

  • Minimum Qualifications:
    • Bachelr’s Degree in Engineering Discipline (please define is any certain discipline is preferred)
    • 3-5 years direct experience
    • Experience in Medical Device manufacturing specifically writing cmpliance documentation
    • In depth knwledge of MS Office tools
    • Must have excellent rganization, clear verbal and written skills
    • Experience wrking in a SDLC-system development lifecycle
    • Hand n skills using navigating equipment user interfaces
    • High level attentin to detail and ability to support multiple priorities at once
    • Must be team-riented with people skills and positive can-do attitude in dealing with a large number of customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc)

 

  • Preferred Qualifications:
    • Experience wrking in FDA-regulated industry
    • Experience wrking with a regulatory body in an audit
    • Perfrmed in a quality role ensuring industry compliance
    • Practical knwledge of 21 CFR Part 11 (electronic records/electronic signature)

 

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: 448122

 


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