Sustaining Engineer – Computer / Software

Key Responsibilities

• Develop, maintain, and optimize test and automation software using LabVIEW, NI TestStand, and Python.
• Write efficient and scalable code in Python for backend testing, data processing, and hardware/software integration.
• Design and implement software solutions that interface with sensors, industrial PCs, DAQ modules, and automated machinery.
• Aid in developing test frameworks, scripts, and utilities used for software/system validation.
• Debug complex code and system behavior across Windows 11, industrial PCs, and embedded device interfaces.
• Support enterprise IT systems used for device commissioning, access control, configuration management, and backup/recovery processes.
• Perform root cause analysis (RCA) on system failures and implement corrective and preventive actions (CAPA).
• Partner with Electrical and Mechanical Engineering teams to investigate complex system behaviors involving hardware/software integration.
• Analyze ambiguous or intermittent production test issues where failures present in subtle, non-obvious ways to users or operators.
• Develop software tools, instrumentation scripts, and diagnostic routines to capture hidden failure modes that traditional hardware diagnostics may not detect.
• Contribute to the creation of advanced test strategies that correlate data across mechanical, electrical, and software subsystems.

Regulatory & Compliance Responsibilities

• Work within FDA 21 CFR Part 820.72 and applicable GMP quality system requirements.
• Ensure data integrity, cybersecurity protections, audit trails, and access controls are properly implemented in test systems.
• Maintain clear, compliant documentation of code, workflows, and validation processes.
• Participate in risk analysis and support validation/verification activities for test equipment and software tools.

Cross-Disciplinary Engineering Support

• Collaborate with cross-functional teams including Manufacturing Engineering, Quality, IT Security, and R&D.
• Translate production and engineering needs into technical requirements for software and test systems.
• Train users and provide engineering support for manufacturing personnel and test technicians.

Required Qualifications

• Bachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field.
• Strong proficiency in: LabVIEW, Python, high-level languages (C++, Java), and associated development environments, scripting languages for automation/test development.
• Experience working with: Windows 11 OS and PC hardware architectures, industrial PCs and automated test hardware, GitHub, source control, debuggers, build systems, TestStand or similar automated test frameworks.
• Hands-on experience debugging complex embedded or computerized systems.
• Familiarity with the software development lifecycle (SDLC).
• Experience with root cause analysis, fault isolation, and system troubleshooting.
• Familiarity with cybersecurity fundamentals related to: Access control, Data protection, System administration, Networked test systems.

Preferred Qualifications

• Prior experience in a medical device or other FDA-regulated industry.
• Knowledge of data integrity requirements, ALCOA/ALCOA+ principles, and digital recordkeeping compliance.
• Experience validating software or equipment under GxP frameworks.
• Background in test equipment calibration, test method validation, or automated manufacturing tools.

Soft Skills

• Strong communication and documentation abilities.
• Detail-oriented with a disciplined approach to working within regulated processes.
• Ability to manage multiple tasks, prioritize effectively, and collaborate across diverse teams.
• Problem-solving mindset with a focus on system reliability and continuous improvement.

Organizational Relationship/Scope

• This position operates cross-functionally and collaborates regularly with Product Performance, Complaint Management, Service Support, Device Quality, Post-Market Surveillance, Device Development, and Materials Management, as well as external partners, to address product lifecycle challenges and support new product introductions.
• The position serves as a key technical resource, providing guidance, influencing decisions, and driving alignment across functions to ensure effective resolution of complex product issues.

Working Conditions

• This role operates across a range of environments, including office, engineering laboratory, and medical device manufacturing areas, supporting hands-on investigation, testing, and product support activities.
• The position requires engagement with both development and production settings to diagnose issues, validate design and process changes, and support ongoing product lifecycle needs.
• Domestic and international travel of up to 20% may be required to support manufacturing sites, suppliers, and field issue investigations.

Disclaimer

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.