Software Test (Manual) Engineer (Medical Device Industry)

About the Role

Key Responsibilities

• Understand the scope and requirements of the project from requirements, user stories, and team interactions.
• Identify conceptual, design, and requirements issues in early testing stages and follow up until resolution.
• Create, modify, and execute exploratory test scenarios to maximize early defect discovery.
• Develop test tools or utilize off-the-shelf tools to increase testing productivity.
• Support the creation of automated regression tests or instructions for automation as per team standards.
• Develop and enhance models of system components that the team works on.
• Create, maintain, and execute test cases and test data.
• Report status and escalate issues effectively.
• Verify the accuracy of product documentation.
• Perform maintenance and upgrades to existing test environments.
• Add value within a team environment consisting of cross-functional members.
• Take direction from lead engineers and communicate issues and results in a timely manner.
• Ensure compliance with all applicable U.S. FDA medical device regulatory requirements, ISO 13485 standards, and other relevant laws and standards.

Requirements

• BS degree or higher in a scientific, engineering, or clinical field.
• Sub-feature or component level QA responsibility experience.
• Basic coding or scripting skills.
• Knowledge of web software, network and IT, medical devices, and regulated environments.
• Working knowledge of DICOM, HL7, SQL, Oracle, IIS, scripting, JavaScript, TFS, MTM, PACS.
• Good verbal and written communication skills.
• Determination to obtain results.
• Passion for using technology to innovate and improve clinician and patient experiences.
• Enjoys working in a team environment.
• Ability to handle fluctuating workloads.
• Ability to see the big picture as well as perform detailed analyses.
• Self-directed and goal-oriented mindset.
• Awareness of and advocacy for industry best practices.

Nice to Have

• DICOM protocol and toolkit experience.
• Previous experience in back-end PACS testing.

Qualifications

• Educational background with a BS degree or higher in a relevant scientific, engineering, or clinical field.

Benefits & Perks

• $65,525.00 - $96,250.00 salary depending on experience.
• 8% MBO Bonus opportunity.
• Medical, Dental, Vision insurance.
• Life Insurance.
• 401k retirement plan.
• Paid Time Off.
• Onsite work environment.