The candidate will participate in product development activities related to the design, development, testing, and/or support of web based software for NxStage Medical s products.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Design, develop, code and unit test software following internal design control SOPs
Apply state-of-the-art methods in creating software for NxStage products; develop improvements to existing designs.
Apply the principles of software configuration management, software life cycle, and software maintainability, as applicable.
Debugging new designs and developing reliability improvements to existing & new design
Participate in multidisciplinary teams, including pairing with other engineers to solve complex problems.
Provide technical support for product engineering, design development, integration, test and evaluation
Follow Design Control SOPs for projects and programs, including following the software development lifecycle.
Work with Quality Assurance to meet the requirements of our internal Quality System, including specific requirements of GMPs, FDA QSR, relevant IEC standards, and ISO 9001.
Assist in Risk Analysis including, Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressed
Assist in developing reports and other data mining activities.
Assist in Integrating NxStage Medical s products with customer systems.
Assist with researching and resolving software related customer complaints.
Ensure all systems and data are protected according to relevant SOPs.
Other duties as assigned.
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.
Occasional travel may be required, normally less than 10%.
BS in Computer Science with a focus on software design and programming.
EXPERIENCE AND REQUIRED SKILLS:
10+ years of experience in software product engineering and development.
Experience in all phases of the software development lifecycle.
Experience in Web GUI design using ASPX and multi-tiered business logic.
Outstanding verbal and written communication skills.
Experience with Microsoft Development Tools.
Experience building ASPX / .Net applications and services
Conduct code reviews, create and maintain requirements and specification documents
Create and execute unit tests as part of software validation efforts
Strong knowledge of project lifecycles, software development environments, and source control techniques.
Experience working in a highly regulated industry, medical device preferred.
Experience and knowledge of cyber security methodologies and testing
Experience with automated testing.
Knowledge of Networks, Network infrastructure and Network protocols
Associated topics: application, back end, develop, devops, programming, python, software development engineer, software engineer, software programmer, sw
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.