Software Test Engineer - Medical Devices

Enterprise Software Test Engineer II

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Enterprise Software Test Engineer II
Job Specific Summary
Job Specific Summary
The Software Test Engineer will focus on supporting medical device software testing. The position is a hands-on test development & individual contributor role with a dynamic set of responsibilities in a complex software system including test design & development, design of test automation framework, test scripts development and test execution.

Responsibilities may include the following and other duties may be assigned:

• Test execution and document software using manual and/or automation methodologies.

• Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices.

• Develop test strategies, review test designs, and validate test scripts, verification of software.

• Provide support for NPTV (Non-product tool validation).

• Navigate the complexities of industry and government regulations to include IEC62304, IEC82304 and FDA QSR (Quality System Regulation) requirements.

• Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals.

• Provide assistance to development teams.

• Commitment to achieving and exceeding project goals and timelines.

• Thrives in working with other disciplines to develop system-minded implementations that consider safety, performance, communication, user interface and other aspects of a final Medical Device product.

• Work in a cross-functional Agile team across global R&D teams to test software for new and existing medical device products.

• Participate in reviews of requirements, design, implement and test to ensure quality standards are met.

• Analyze unexpected, undesirable, or non-understood behavior in software and in interactions of software with hardware.

• Document results of defect analysis.

• Follow the IEC 62304 standard and project documents such as the software development plan and coding standards.

• Participates in other quality assurance functions, including, but not limited to, static code analysis, risk/hazard analysis, and test automation development.

• Should be an excellent team player with good communication skills.

• Should meet key business KPI/project metrices.

Required knowledge and Experience:

• A Bachelor’s degree in Computer science, Electrical, Electronics / equivalent from reputed institution.

• 4 to 8 years’ experience in Software verification & Validation with at least two (2) years’ experience in the Medical device/Medical IT or regulated industry.

• Experience in test automation preferably using Java, Groovy, Selenium, Appium.

• Experience on both white box and black box testing and strong debugging skills.

• Experience in hardware/software interfacing and design issues.

• Participate in System design, coordination with teams and internal product management.

• Experience with software risk analysis (per ISO 14971) including software failure mode and effects analysis (FMEA).

• Awareness of Medical Device standards IEC 60601-1, IEC 62304, ISO 13485, ISO 14971, and applicable FDA standards

• Excellent debugging skills and problem-solving capabilities

• Experience working in a structured software development environment following a well-defined software development process like Agile / Lean.

• Must be a great individual contributor and team player.

• Must have qualities including being positive, high standards, resilient, open, and creative.

• Appreciation of discipline and work required to develop software in a regulated industry.

 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

 

 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here  

Experience Level

Mid Level