Sr. Quality Engineer
The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxSTAGE Medical, Inc. maintains the right to modify this list at any time.
NxStage® Medical Inc. is a medical device company that develops, manufactures, and markets innovative systems for the treatment of end-stage renal disease and acute kidney failure. Many home patients enjoy the freedom and flexibility of the System One™ hemodialysis machine, the first truly portable system indicated for home hemodialysis. Over the last three years, NxStage has become one of the fastest growing companies in Massachusetts, and Forbes Magazine recently ranked us the 53rd fastest growing company in North America. In hospital ICUs, NxStage is the equipment of choice for 8 of the top 10 kidney disease hospitals (as ranked by US News World Report). Medisystems, a NxStage company, is the market leader in tubing and access needle products in US dialysis centers. Come join us during this exciting time in our growth as a company!
Summary
The incumbent applies software 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.
Specific Duties
- Work with internal groups in creating project documents, and performing verification and validation testing required in an FDA-regulated environment.
- Responsible for generating and presenting software quality metric data to others within the company.
- Lead project teams in assessing the required validation activities for software systems.
- Develop and execute procedures and scripts meant to test the performance of the following software:
- Software contained in NxStage commercially distributed products.
- Software used in the manufacture and/or testing of NxStage products.
- Software used in NxStage quality systems.
- Lead team reviews related to software validation
- Perform device system and performance testing in the lab.
- Develop testing strategies and software risk analyses.
- Develop and implement quality metrics associated with software development and performance.
- Responsible for monitoring regulatory environment and for making the necessary changes to NxStage procedures to ensure compliance.
- Develop and implement continuous improvement activities related to the development of and configuration management of NxStage software.
Requirements
- B.S. in Computer Science or Engineering Related Field
- M.S. in Computer Science or Engineering Related Field Preferred
- 5+ years related quality assurance, software quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
- ASQ certification a plus.
- Experience working with medical grade plastics, and plastic processes.
- 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.
- Ability to interface with multiple groups in the organization.
- Systems - Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.
- Software - Computer skills – C++, C, object oriented design, embedded software design, web design, database design, SQL server and Access, automated testing, data security.
- Willingness to contribute to other departments as necessary
Please, no phone calls regarding this job posting.
NxStage is an Equal Opportunity Employer
The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxSTAGE Medical, Inc. maintains the right to modify this list at any time.