Senior Manufacturing Test Engineer

This role ensures product quality and reliability by designing robust test methods, developing scalable software-driven solutions, and owning the full equipment validation lifecycle, including in-house Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and IQ/OQ/PQ. Senior Manufacturing Test Engineer Job Summary: The Senior Manufacturing Test Engineer leads the development, implementation, and optimization of manufacturing test processes and advanced automated test systems.

Senior Manufacturing Test Engineer Job Summary:

• The Senior Manufacturing Test Engineer leads the development, implementation, and optimization of manufacturing test processes and advanced automated test systems.
• This role ensures product quality and reliability by designing robust test methods, developing scalable software-driven solutions, and owning the full equipment validation lifecycle, including in-house Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and IQ/OQ/PQ.
• The role also drives technical leadership, standardization, and continuous improvement across manufacturing operations.

$110k - $130k
Direct Hire Key Responsibilities:

• Lead design, development, and validation of manufacturing test methods, fixtures, and complex automated test systems
• Architect, develop, and maintain scalable test software using Python for data acquisition, execution, and analysis
• Integrate test hardware with software platforms (DAQ systems, sensors, PLCs) and ensure system-level performance
• Drive test automation, data integrity, and system standardization across manufacturing lines
• Define and lead test strategy for new product introduction (NPI) and scale to production
• Own and lead in-house Factory Acceptance Testing (FAT) to verify equipment functionality and performance
• Lead Site Acceptance Testing (SAT), installation, and commissioning activities
• Define and drive full validation lifecycle (IQ/OQ/PQ) including protocol development and execution
• Troubleshoot complex system-level issues across hardware, software, and processes
• Analyze large datasets using Python, SQL, or similar tools to drive yield improvement and cost reduction
• Collaborate and lead cross-functional technical discussions with R&D, Quality, Manufacturing, and leadership
• Develop and maintain test documentation, software scripts, FAT/SAT protocols, and validation reports
• Ensure compliance with regulatory standards (FDA, ISO 13485, GMP)
• Mentor junior engineers and technicians
• Lead continuous improvement initiatives and test automation roadmap development

Required Qualifications:

• Bachelor’s (Master’s preferred) in Electrical, Mechanical, Biomedical, Computer Engineering, or related field
• 5–8+ years of experience in manufacturing test engineering
• Advanced experience with Python programming (test automation, data analysis, equipment control)
• Strong experience leading in-house FAT/SAT and validation (IQ/OQ/PQ)
• Deep knowledge of test equipment and systems (DAQ, sensors, PLCs, automation)
• Strong problem-solving and root cause analysis skills (5 Whys, Fishbone, DOE)

Preferred Qualifications:

• Experience designing custom automated equipment and test platforms
• Strong data analytics and visualization skills (Python, SQL, Pandas)
• Experience with MES systems and digital manufacturing integration
• Medical device or highly regulated industry experience
• Lean / Six Sigma certification (Black Belt preferred)

Key Competencies:

• Technical leadership and system-level thinking
• Strong software + hardware integration expertise
• Ownership of full validation lifecycle (FAT / SAT/IQ/OQ/PQ)
• Hands-on troubleshooting across hardware and software systems
• Strategic mindset with strong execution capability
• Excellent cross-functional communication and leadership skills