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Senior Systems Engineer

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Onsite
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Locations:  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 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 Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document, 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 Requests 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 guidance, mentoring and training to Engineer I's & II's.  Ensure consistency of work among Engineer I's & II's.  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: 

Required Qualifications

  • Bachelors (5+ year experience) or Masters (3+ year experience) in Electrical Engineering, Computer Engineering, Computer Science or related fields
  • 5+ year experience in software/hardware engineering.
  • 5+ year experience automated and manual testing in cardiac medical device domain.
  • 2+ year experience in system development lifecycle process including formalized processes and procedures.
  • Ability to collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations from all stakeholders using all sources of data.
  • Ability to analyze test results and perform risk analysis required.
  • Ability to interpret and apply regulations and standards relevant to class II/III medical devices required.
  • Ability to interpret and research system requirements, system specifications, input/output process and working parameter by using current systems engineering methods.

 

Requisition ID: 553980

 

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!

 

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Nearest Major Market: Minneapolis

Job Segment: Medical Device, Systems Engineer, Medical Device Engineer, Testing, Electrical Engineering, Engineering, Healthcare, Technology

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