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 equivalent industry experience.

 

Preferred Qualifications:

• Experience with data processing and reporting systems.
• Experience with medical manufacturing systems and processes.
• 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
• Intermediate Python programming.
• 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.
• Experience in using documentation, task, defect, requirement, and test case management systems such as Oracle Agile PLM, Jira, ValGenesis, or similar.
• Expertise in 21 CFR Part 11 compliant systems.
• Familiarity with 21 CFR 820 a plus.
• Experience with ISA 95 model a strong plus.

 

Travel Required:

• Up to 25%

 

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.