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Principal Test Engineer - Human Factors Usability and Validation
Medtronic - Lafayette, CO
posted 2 months ago
About the position
The Principal Test Engineer at Medtronic is responsible for leading a team of Test Engineers in the development and execution of verification and validation activities for software and systems. This role focuses on ensuring that Medtronic's medical products meet user needs and adhere to quality and reliability standards. The position requires technical expertise, team leadership, and strategic direction in Test Engineering, contributing to the development, production, and service of products in the global marketplace.
Responsibilities
- Lead a team of Test Engineers to develop and perform verification & validation activities for software and systems.
- Coordinate activities of the validation team to ensure project timeliness to goals, objectives, and milestones.
- Plan and conduct user validation testing, including user recruiting, designing and conducting usability tests, summarizing, documenting and communicating results.
- Ensure compliance with standards and regulations, including ISO and FDA QSR.
- Participate in all phases of product development such as reviewing requirements, design, usability, risk assessment and defects.
- Provide technical leadership and mentoring to other test engineers.
- Identify, plan, and execute test process improvements to enhance the performance of the Test Engineering team.
- Develop new approaches to solve problems.
- Maintain proficiency in the use of testing tools and methodologies.
- Effectively communicate and present findings, problems, and solutions within the team and organization.
- Collaborate and maintain excellent working relationships with team members and stakeholders.
Requirements
- Bachelor's degree in a technically related field is required.
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
Nice-to-haves
- Proven leadership skills and mentoring capabilities.
- Able to handle multiple tasks/projects and manage priorities.
- Experience with Agile and iterative development practices.
- Strong understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971, 62304, 62366 and 13485, and EU MDR.
- Excellent interpersonal, written, and verbal communications, time management, and organizational skills.
- Experience engaging clinicians and gathering VoX feedback from customers.
- Experience with usability validation and human factors (IEC 62366).
- Experience with verification or design of complex software and hardware systems.
- Understanding of software development methodologies and software lifecycle.
- Ability to work in a team environment.
Benefits
- Competitive Salary
- Flexible Benefits Package
- Short-term incentive called the Medtronic Incentive Plan (MIP)
