What are the responsibilities and job description for the Quality Engineer software - Medical device position at Intellectt Inc?
Role: Software Quality Engineer
Location: Sylmar, CA
Duration: 6 Months and possible extension
This position works out of our Sylmar, CA, location in the Cardiac Rhythm Management division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Sr. Software Quality Engineer is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures
What You’ll Work On
Location: Sylmar, CA
Duration: 6 Months and possible extension
This position works out of our Sylmar, CA, location in the Cardiac Rhythm Management division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Sr. Software Quality Engineer is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures
What You’ll Work On
- Provide guidance and training to the site engineers for the Software Validation, Data Integrity, Software Requirement Specification (SRS), and also other support software systems.
- Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
- Participate in reviews for System and Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.
- Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports
- Use test equipment and instrumentation to obtain test data from the devices and be capable of analyzing the data
- Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
- Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks.
- Analyze and/or provide feedback on software cybersecurity and data integrity.
- Review and approve Non-Product Software (NPS) assessment, Data Integrity assessments and Risk Analysis assessment to comply with FDA 21 CFR Part 11.
- Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
- eSupport internal (corporate and divisional) and external quality audit
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelor’s Degree Engineering (Electrical/Computer Engineering preferred) or Technical Field OR an equivalent combination of education and work experience
- Minimum 7 years
- Experience in firmware or embedded software testing and verification/validation preferred.
- Software Quality Engineering experience
- Cybersecurity and Data Integrity knowledge of SDLC preferred.
- Experience working with Bluetooth enabled systems and related software/firmware testing preferred.
- Experience with unit- and integration-level testing and automated testing is recommended.
- Programming experience in C/C /C#, Scripting Language such as Python.
- Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
- Detailed knowledge of FDA part 820, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired.
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