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Lead Software Quality Assurance Engineer

2 months ago


Eden Prairie, Minnesota, United States ACIST Medical Systems Full time


Why Join ACIST Medical Systems?
At ACIST Medical Systems, we are dedicated to making a difference in healthcare through innovative medical technologies.

Our advanced medical devices provide healthcare professionals with the essential tools to make informed and timely decisions for patient care.


Position Overview:

The Lead Software Quality Assurance Engineer is a vital contributor to the software development team at ACIST Medical Systems. This role focuses on the creation and execution of verification and integration testing software for our diverse range of medical devices.

As part of our global R&D software engineering team, you will engage in all stages of the software development lifecycle, emphasizing verification, validation, and integration testing of medical devices and connectivity solutions.

This position requires a strong foundation in software testing to effectively translate product specifications into comprehensive test strategies, ensuring adherence to a regulated Product Development Process (PDP) and Quality Management System (QMS).


Key Responsibilities:

- Develop innovative solutions to enhance customer experience and operational efficiency.
- Oversee software testing for medical device connectivity and related systems.
- Formulate test protocols for software verification and validation based on established requirements.
- Collaborate with software architects and systems engineers to ensure compliance with specifications and readiness for testing.
- Design, implement, and maintain software testing components, applications, and tools.

Participate in product development phases, including requirement reviews, architecture assessments, design evaluations, and usability testing.

- Foster a culture of engineering excellence and commitment to quality.
- Contribute to the development of overall software test strategies and integration plans.
- Generate detailed test reports documenting results and coverage of requirements.
- Provide insights to project teams regarding effort estimation and resource allocation.
- Collaborate with external vendors on testing strategies for interoperability standards.


Qualifications:

Minimum:
- Bachelor’s degree in Computer Engineering, Computer Science, Software Engineering, Electrical Engineering, or a related field.
- 5+ years of experience in software development and testing.
- 2+ years of experience with test scripting.
- Proficiency in a scripting language (e.g., Python).

Preferred:
- Master’s degree in a relevant field.
- 5+ years of experience with C# and 2+ years with Python.
- Familiarity with regulatory standards such as QSR and ISO/EN.
- Experience with test automation frameworks and tools.

- Strong analytical skills and the ability to work collaboratively within a global team.
- Knowledge of clinical terminology and medical device interoperability standards.


Other:

- Adhere to all company policies and ethical standards.
- Willingness to travel as needed.