PURPOSE AND SCOPE:
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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Develop concise test protocols/procedures by analyzing complex technical requirements for
- Software contained in NxStage commercially distributed products
- Software used in 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 identified 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
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Extended computer-based work in an office environment.
- B.S. in Computer Science or Engineering Related Field
EXPERIENCE AND REQUIRED SKILLS:
- 5 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
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.