Principal Software Automation Test Engineer – Medical Devices
About The Position
As a test engineer within the CST Enabling Technologies Platforms and Solutions Research and Development organization, you will utilize your expertise in test and engineering to deliver cutting-edge intra-operative imaging, navigation, and robotic-assisted surgery technology to improve patient outcomes and surgical efficiency. The Cranial & Spinal Technologies (CST) business develops life-restoring therapies and healthcare solutions that span the care continuum, integrating technologies and applying clinical and economic evidence to increase patient access, improve the efficiency of procedures, and deliver successful patient outcomes. This role involves evaluating requirements for quality and completeness, developing test methods, leading automated test strategy and implementation, reducing test burden through automation, and planning/implementing automation using tools like LabView and TestComplete. You will also design standalone automation applications, use AI tools for testing and documentation, test advanced image reconstruction and processing algorithms, and participate in all phases of product development. Responsibilities include identifying and cataloging software defects, assisting in defect triage and resolution, identifying, planning, and executing test process improvements, generating test protocols, setting up and using physical imaging phantoms, documenting and reporting test results, communicating findings, collaborating with team members and stakeholders, and performing all activities in compliance with the Quality System and environmental, health, and safety regulations.
Requirements
- BS degree in a related engineering discipline required (software, biomedical, etc.)
- Minimum of 8 years relevant experience
Nice To Haves
- Able to handle multiple tasks/projects
- Experience with Agile and iterative development practices
- Experience with development within a regulated environment
- Understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971, 62304, and 13485, and EU MDR
- Experience with LabView or TestComplete
- Excellent interpersonal, written, and verbal communications, time management, and organizational skills
Responsibilities
- Evaluate requirements for quality and completeness to ensure they meet the user needs.
- Develop test methods to be used in verification.
- Lead over all automated test strategy and implementation.
- Reduce overall test burden through structured automation of existing and new testing.
- Plan and Implement automation using LabView, TestComplete, and similar utilities.
- Design stand-alone automation applications as needed for specialized functionality.
- Use of AI tools for developing testing, automation, and documentation.
- Testing of advanced image reconstruction and processing algorithms.
- Participate in all phases of product development as needed such as reviewing requirements, design, usability, risk assessment and defects.
- Responsible for identifying and cataloging of software defects in assigned functional areas.
- Assist in triage, investigation and resolution of software defects.
- Identifies, plans and executes test process improvements as a means to continually improve the performance of the Test Engineering team.
- Generates test protocols based on product requirements and project needs.
- Set up and use of physical imaging phantoms.
- Document and report test results.
- Effectively communicate and present findings.
- Collaborate and maintain excellent working relationships with team members and stakeholders.
- Perform all activities in compliance with the Quality System.
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
- All other duties as assigned.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
