Test Engineer

Actalent; Wisconsin; On-site; USD 75,000 - 105,000; Full time

Job summary

Actalent is seeking a Test Engineer to support and improve automated test systems and manufacturing software for FDA-regulated medical devices. The role centers on developing and maintaining test solutions using LabVIEW, Python, and TestStand to ensure reliable production testing.

The position requires 3+ years in test engineering, strong debugging skills, and familiarity with FDA/GMP requirements. Collaboration with manufacturing, quality, IT, and R&D teams is essential to drive quality and

Qualifications

• 3+ years of experience in test engineering in automated production environments.
• Proficiency with NI LabVIEW for developing automated test applications.
• 3+ years of Python scripting for backend testing and automation.
• Experience with test equipment, fixtures, and production/test procedures.
• Knowledge of FDA and GMP requirements and regulatory compliance.

Responsibilities

• Support and enhance automated test systems and manufacturing software used in production of FDA-regulated medical devices.
• Develop, maintain, and improve test applications using LabVIEW, Python, TestStand, and related tools.
• Troubleshoot complex hardware and software issues in test systems including fixtures and test scripts.
• Perform detailed root cause analysis of test system failures and implement corrective actions.
• Improve test system reliability, performance, and throughput by optimizing test procedures and configurations.
• Ensure test systems and related software comply with FDA and GMP requirements throughout the product lifecycle.
• Maintain and update validation documentation for test systems, including protocols and reports.
• Collaborate with manufacturing, quality, IT, electrical, mechanical, and R&D teams to resolve production issues.
• Design, develop, and refine automated diagnostic tools and test automation solutions for manufacturing.
• Support sustaining engineering and manage product lifecycle issues related to test systems.

Skills

Automated test systems

Python scripting

LabVIEW development

C/C++ programming

Root cause analysis

Regulatory compliance

Lean Six Sigma / ISO 9001 familiarity

Education

Bachelor's degree in Computer Science or Software Engineering

Tools

NI LabVIEW

TestStand

Python

C/C++

Test equipment

Job description

Job Description

Job Description

Job Title: Test Engineer

Job Description

This role focuses on supporting and improving automated test systems and manufacturing software for FDA-regulated medical devices. The test engineer develops, maintains, and enhances test solutions using LabVIEW, Python, TestStand, and related engineering tools to ensure reliable, compliant, and efficient production testing. The position plays a key role in troubleshooting complex issues, maintaining regulatory compliance, and collaborating with cross-functional teams to deliver high-quality medical products.

Responsibilities

• Support and enhance automated test systems and manufacturing software used in the production of FDA-regulated medical devices.
• Develop, maintain, and improve test applications using LabVIEW, Python, TestStand, and other engineering tools.
• Troubleshoot complex hardware and software issues in test systems, including test equipment, fixtures, and test scripts.
• Perform detailed root cause analysis of test system failures and production issues, and implement robust corrective actions.
• Improve test system reliability, performance, and throughput by optimizing test procedures, test code, and test equipment configurations.
• Ensure test systems and related software comply with FDA and Good Manufacturing Practice (GMP) requirements throughout the product lifecycle.
• Maintain and update validation documentation for test systems, including protocols, reports, and supporting evidence.
• Implement and support cybersecurity controls and data integrity standards for test systems and manufacturing software.
• Collaborate closely with manufacturing, quality, IT, electrical, mechanical, and R&D teams to investigate production issues and develop solutions.
• Design, develop, and refine automated diagnostic tools and advanced test automation solutions to support manufacturing and sustaining engineering.
• Support sustaining engineering activities and manage product lifecycle issues as they relate to test systems and manufacturing test processes.
• Work with contract manufacturers and global supply chain partners to support test system deployment, maintenance, and continuous improvement.
• Apply Lean Manufacturing, Six Sigma, or ISO 9001 practices to improve test processes, reduce defects, and enhance overall quality.
• Utilize component lifecycle management tools and change control processes to manage updates to test systems, fixtures, and software.

Essential Skills

• 3+ years of experience in test engineering, with a focus on automated test systems and manufacturing test environments.
• 3+ years of experience with NI LabVIEW for developing and maintaining automated test applications.
• 3+ years of experience with Python scripting, particularly for backend testing and automation.
• Hands‑on experience with test equipment, test fixtures, and test procedures in a production or regulated environment.
• Proficiency in test development tools and programming languages such as LabVIEW, Python, TestStand, and C/C++.
• Experience troubleshooting complex hardware and software issues in test systems and performing root cause analysis.
• Experience supporting sustaining engineering and managing product lifecycle issues related to test systems.
• Knowledge of FDA and GMP requirements as they apply to test systems, validation, and manufacturing software.
• Understanding of cybersecurity controls and data integrity practices for test and manufacturing systems.
• Familiarity with Lean Manufacturing, Six Sigma, or ISO 9001 practices in a production or test environment.
• Experience working with contract manufacturers and global supply chains to support test and manufacturing processes.
• Knowledge of component lifecycle management tools and change control processes.
• Bachelor's degree in Computer Science, Software Engineering, or a related engineering or technical discipline.

Additional Skills & Qualifications

• Experience designing automated test systems and fixtures, including both mechanical and electrical aspects.
• Experience maintaining validation documentation and supporting audits related to test systems.
• Ability to collaborate effectively with cross-functional teams, including manufacturing, quality, IT, electrical, mechanical, and R&D.
• Strong analytical and problem‑solving skills, with a focus on improving reliability and performance of test systems.
• Exposure to advanced diagnostic tools and automation frameworks for manufacturing test environments.
• Familiarity with global supply chain considerations and working with external manufacturing partners.
• Interest in