US_East | Product / System & PLM Engineer_L3

System Test Engineer

This position requires an engineer with strong expertise in system verification and a deep understanding of the product development life cycle, particularly for electro-mechanical medical devices. The ideal candidate will be responsible for designing, developing, and verifying test methods and protocols on a Linux-based platform to ensure the quality and reliability of software applications.

Key Responsibilities:

• Design and develop system verification test methods and protocols aligned with product requirements
• Define and analyze system requirements, clinical workflows, and input/output processes using systems engineering methods
• Perform system verification of electro-mechanical and mixed hardware/software medical devices
• Support full product lifecycle verification from requirements understanding to validation completion
• Execute functional, performance, and stress testing to validate system reliability
• Create test setups, including troubleshooting and maintaining test fixtures for consistent data collection
• Conduct test method validation and ensure objective evidence collection based on intended use
• Identify risks, perform failure mode analysis, and develop verification test cases
• Document system architecture, design control artifacts, reports, and technical memos
• Collaborate with QA, RA, R&D, and cross-functional engineering teams
• Lead and support industry compliance testing, including safety and EMC standards (IEC 60601-1)
• Execute tests using Linux-based workstations and maintain test environments
• Analyze requirements and translate them into structured verification plans and test cases
• Report bugs, track issues, and work with development teams for resolution

Required Skills & Experience:

• Strong knowledge of QMS, SOPs, and regulated medical device environments
• Hands-on experience in remediation programs (gap analysis, DHF, design, and compliance remediation)
• 6–7 years of total experience with at least 3–4 years in medical device system verification
• Experience completing at least two full product lifecycle verification cycles
• Strong experience in electro-mechanical system verification in lab environments
• Knowledge of risk management, failure mode analysis, and verification protocol writing
• Experience with Linux operating systems in testing environments
• Strong documentation and stakeholder communication skills
• Knowledge of programming languages such as Python, Java, or C++ (preferred)

Good to Have:

• Experience with laboratory equipment (DSO, multimeter, logic analyzer)
• Understanding of analog and digital electronics (DC-DC converters, sensors, microcontrollers)
• Hands-on experience with MATLAB and Python
• Familiarity with Agile development methodologies

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.