Position Summary:
As a SW system engineer on the ITOT Team you will plan and generate manufacturing software test plans and protocol based on the software system requirement, design and perform automated and manual software testing on manufacturing equipment supporting FDA-regulated manufacturing processes.
Essential Duties and Responsibilities:
- Assist with development of test plans, test cases, and test scripts on multiple projects simultaneously.
- Experience with medical or similar regulated manufacturing systems and processes.
- Experience with positive and negative outcomes in the manufacturing process with a focus on failure and reject modes.
- Independently define and enforce the strategies for integration, system, and regression testing and test environment during V&V.
- Create, track, and complete regulated documentation for SW V&V process such as change orders, test plans, reports, and relevant attachments.
- Review and update documentation in response to feedback from stakeholders.
- Participate in design review and change control meetings.
- Work with developers or vendors to perform root-cause analysis and preliminary problem diagnosis.
- Identify defects and track them from discovery to resolution.
- Conduct manual and automated testing of software.
- Quickly learn all essential aspects of fast paced manufacturing testing system.
- Basic SQL Knowledge for (SELECTS, JOINS, and execution)
- Other duties as assigned
Required Qualifications:
- Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5 years related experience or Master's degree and 3 years of equivalent industry experience.
Preferred Qualifications:
- Experience with data processing and reporting systems.
- Proficient in all software testing phases.
- Understand medical device software development process and participate in efforts to improve SDLC processes.
- Extensive experience working as a quality engineer for product manufacturing software or developing or validating software for product manufacturing equipment.
- Quick learner and adjust easily to a dynamic, fast paced environment
- SQL query modification and execution.
- User Interface testing experience.
- Familiar with JIRA, Valgenesis, and/or Smartsheet.
- Experience in software for operating manufacturing or testing equipment.
- Experience in FDA regulated software development.
- Python programming a plus.
- Experience in using documentation, task, defect, requirement, and test case management systems such as Oracle Agile PLM, Jira, ValGenesis, or similar.
- Experience with 21 CFR Part 11 compliant systems.
- Familiarity with 21 CFR 820 a plus.
- Experience with ISA 95 model a strong plus.
Travel Required:
Functional Description: Technical Individual Contributor
Designs, develops, troubleshoots, and debugs software test cases and strategies based off requirements. Gives feedback on testing and requirements as needed.
Functional/Business Knowledge:
- Possesses knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.
Scope:
- Demonstrates technical expertise, collaboration with others, and independent thought. Anticipates potential complex problems requiring an in-depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.
Judgement:
- Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
- Determines methods and procedures on new assignments.
