Software Design Assurance Engineer I Job in Sylmar 91342, California US

Position for a Software Design Assurance Engineer I who will support development and verification of software used in St. Jude Medical-CRMD products.

·         Possess a solid understanding of software development, verification and validation activities, processes, approaches, and methodologies.

·         Work with Software Engineers on the software development process, including document review, technical review meetings, change control meetings and auditing.

·         Develop and execute audits on software project documentation according to FDA Design Controls and IEC 62304.

·         Monitor software configuration management, defect tracking and requirements using software tools such as ClearCase, ClearQuest and DOORs.

·         Implement process improvements that add value to software development projects, contribute to finding bugs earlier, and prevent failures from reaching the field.

·         Conduct review meetings for issues found during audits and ensure that all issues are resolved before regulatory submission.

·         Develop, follow and maintain internal SOPs, department work instructions, project audit plans and audit summary reports.

·         Schedule and perform software validations as needed for quality system software used throughout the company.

·         Support other departments in the validation of software for quality systems, including in-house and commercially developed software.

·         Must possess excellent oral and written communication skills with the ability to effectively convey schedules, issues, and results in documents, emails, and meetings.

·         Must be able to complete projects on schedule with a high quality results.

·         Must be a detail oriented person who can diplomatically catch mistakes and get corrections made.

·         Must have high energy and enthusiasm with a history of successful team participation.

·         Must be a local candidate.

 

We are looking for a mature and responsible new grad (or soon-to-be grad) with a degree in Software Engineering, Computer Engineering or Computer Science and who has elective coursework in some of the following areas:

·         UNIX

·         Computer Security

·         Data Security and Encryption Techniques

·         Software Testing

·         Software Process

·         Software Quality

·         Data Mining and Pattern Recognition

·         Web Programming and Data Management

 

Please send your resume to:mvanwormer@sjm.com