Fresenius Medical Care Job - 37267966 | CareerArc
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Company: Fresenius Medical Care
Location: Lawrence, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


Job ID 210001CN

Available Openings 1

Position Summary:

The incumbent applies software and/or systems engineering and quality assurance principles and techniques to the software and product development lifecycles. The position will also perform software and/or system testing for NxStage medical devices and other business software and/or systems that supports the Quality System.


Develop concise test protocols/procedures by analyzing complex technical requirements for

Software contained in NxStage commercially distributed products.

  • Software used in the manufacture and/or testing of NxStage products.
  • Software used in NxStage quality systems.
  • Demonstrate ability to establish test methodologies and acceptance criteria, execution of test protocols, data analysis, investigation, and writing final reports.
  • Demonstrate competency with in writing feature level test design with systems level knowledge and workflow
  • Perform regression analysis/testing and associated documentation on software release changes
  • Demonstrate understanding of complete software lifecycle phases
  • Experience in a team oriented traditional waterfall or fast-paced agile development processes, working closely with developers during feature development and testing phases
  • Support risk management activities to ensure software design protective measures are indentified and verified.
  • Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
  • Develop and implement quality metrics associated with software development and performance.
  • Research emerging test and automation trends/tools and implement continuous improvement activities to the testing methodologies and practices.


  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.


Bachelor's Degree required in Computer Science, Software Engineering, or related field.


  • 3+ years related quality assurance, software quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
  • 2+ years experience with embedded software or real-time devices/systems level testing required
  • ASQ certification a plus.
  • Advanced working knowledge of FDA Quality System Regulation 21 CFR Part 820.
  • Good organizational, attention to detail and follow-through skills
  • Excellent verbal communication and customer interface skills required.
  • Ability to interface with multiple groups in the organization
  • Experience with structured programming languages and scripting desired
  • Software - Computer skills – C++, C, and object oriented design, embedded software design, web design, database design, SQL server and Access, automated testing, data security.

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

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