Engineer - Degreed IV_SJM

Sr Software Quality Engineer NPS Validation

• Know the fundamental of programming.
• Have ability to communicate effectively with any assigned teams and work with them to achieve project goals on time and in good quality. Ability to work in a highly matrixed and geographically diverse business environment
• Be an independent team asset.
• Support Design Verification and Validation planning & execution, including active cross- functional root-cause analysis investigation & resolution activities and ensure the software meets organization and customer quality and specifications
• Test/quality experience and/or technical writing is a plus.
• Hands-on production equipment experience is a plus.
• Experience in Software Validation
• Software Testing experience
• Bachelor's degree, or advance degree in Computer Science, Computer Engineering or Electrical Engineering
• Contribute to design reviews, risk analyses, and document reviews
• Multitasks, prioritizes and meets deadlines in timely manner
• Software scoping and Part 11 audits.
• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
• Create and execute or direct software validation protocols traceable to system/software requirements
• Analyze test data to identify the product quality or defects with a goal of mitigating and preventing recurrence and future defects.
• Performs other duties as assigned.

Preferred:

• Medical Device software experience, knowledge of design controls, risk management.
• Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
• Execute and support on-time completion of Design Control Deliverables
• Performs Software Configuration Management tasks
• Experience with systems engineering, system requirements management, and system level risk management strategies
• Experience with ATE and Non- Product Software validation
• Strong foundation in computer science, with strong competencies in data structures, algorithms, and software design with SW development languages like Python, C, C++, C#, LABVIEW etc.
• Capable of deep-dives into code
• Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.