Principal Test System Software Engineer

About the Role

Key Responsibilities

• Provide end to end development of software solutions for custom functional test systems including test system architecture development and integration, acceptance testing, and technical support.
• Provide technical leadership on projects involving multiple engineers, including leading the overall software design approach, partitioning work among the team, and directing detailed software design activities to support the project schedule.
• Develop next-generation software test system requirements through collaboration with key stakeholders, product benchmarking, and input from industry standards.
• Decompose device-level requirements and use-cases into test system software requirements.
• Ensure allocation of software functions across software modules enables optimal control system performance and meets software architecture design needs.
• Lead physical and virtual design reviews to confirm confidence in designs prior to program milestones.
• Resolve technical issues by applying problem-solving techniques and facilitating cross-functional support from Engineering, Manufacturing, and Test Organizations.
• Collaborate closely with product team members to develop test equipment and methods to expedite the delivery of new products.
• Specify, design, implement, verify, validate, debug, and support test system software, hardware, tools, and utilities.
• Work with vendors developing tests and test equipment.
• Design, build, and manage cloud-based production test control systems.
• Generate documentation supporting verification and validation activities, including test methods and test reports.
• Continuously evaluate and improve processes by collaborating with cross-functional groups.
• Collaborate with manufacturing and operations to support IQ/PQ/TMV of new test systems.
• Engage in architecture, design, and code reviews to ensure designs meet or exceed implementation, testing, scalability, and maintainability best practice guidelines.
• Ensure all quality system, regulatory, legal, and business requirements are met in product development and market delivery.

Requirements

• Bachelor degree in Software Engineering, Software Engineering, or related Science or Engineering degree.
• 8+ years of experience in a similar role, including automation/manual testing experience.
• Experience working with standards for good laboratory practices (GLP), good manufacturing practices (GMP), and/or good clinical practices (GCP).
• Experience establishing/building relationships with internal resources, contract resources, and large vendors.
• Demonstrated analytical skills.
• Design and Architecture using Python.
• Automated test system design.

Nice to Have

• Master degree in Software Engineering, Software Engineering, or related Science or Engineering degree.
• Experience with automated software test tools and techniques.
• Active implantable or Class III medical product development experience.
• Experience developing test system architectures.
• Experience developing in LabView.
• Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366.
• Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development, and manufacturing.

Benefits & Perks

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• Participation in ownership and success through equity awards and Employee Stock Purchase Program.