Senior Engineer

Senior Engineer, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Concord, California (Hybrid)

Will contribute to the development and execution of system verification plans, protocols, and reports for a medical device manufacturer by analyzing system requirements for medical device products. Duties will include:

• Provide leadership to team members on best practices for Verification and Validation execution as it applies to key medical device methodologies, FDA design controls and quality system requirements.
• Lead verification plans and protocol reviews and help the broader Team migrate to more agile development methodologies.  Ensure that verification documents follow internal Fresenius guidelines and processes for embedded software functionality per the Quality Systems Regulations (21 CFR part 820) and ISO 13485 standards. 
• Design and develop verification tools and systems required to ensure the proper and regulatory compliant operation of hemodialysis and peritoneal dialysis medical devices.  Select and configure tools for exercising and collecting data from completed and implemented test cases in compliance with ISO 62304, ISO 13485 QMS and ISO 14971 Risk Management.
• Design and conduct tests and write test protocols for evaluating and analyzing all aspects of medical software safety. Generating comprehensive test reports from executed test protocols that ensure output content complies with dialysis treatment safety levels and expected outcomes.
• Design and develop tools and systems that can diagnose performance issues with embedded systems and can track medical data generated by our devices. 
• Design and develop medical diagnostic and clinical instrumentation, equipment, and procedures, using the principles of engineering and biobehavioral sciences/Human Factors Engineering.
• Provide technical support for biomedical devices.
• Design and develop verification tools and process to address new or enhanced functionality of medical devices.
• Define, approve and execute test protocols and write reports to describe program evaluation, testing, and correction.  Performing both positive and negative dialysis treatment tests on equipment for thorough coverage and creating regression tests to verify defects found during execution of test protocols and ensuring end-to-end clinical use cases are represented.
• Serve as a primary embedded and systems-level software verification liaison and provide recommendations and guidance on testing and assessing the functionality of medical devices in development. 

Requirements:

Position requires either (i) a Master’s degree (or an equivalent foreign degree) in Chemical, Biomedical, Electrical or Mechanical Engineering or a closely related field and 3 years of experience as a Validation/Verification Engineer for medical device systems or (ii)  a Bachelor’s degree (or an equivalent foreign degree) in Chemical, Biomedical, Electrical or Mechanical Engineering or a closely related field and 5 years of experience as a Validation/Verification Engineer for medical device systems. 

Must also have 3 years of experience (which can have been gained concurrently with either primary experience requirement above) working with the following:

• Design Control, software development in accordance with IEC 62304 and testing standards across medical device and software;
• Performing system functional and performance testing and building Test Methods, using tools/equipment to simulate fault conditions/errors and acquire evidences;
• Designing test cases for software, component, and system-level requirements for medical devices; and
• Leading and managing test and verification activities under medical device design controls, including authoring formal test plans, managing resources, overseeing lab logistics, organizing protocol execution, and reporting results.

This is a hybrid position working 3 days/week at the office in Concord, CA and 2 days/week from home.

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

EOE, disability/veterans