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

Description

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.

Responsibilities:

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.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

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

EDUCATION:

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

EXPERIENCE AND REQUIRED SKILLS:

  • 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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