Test Engineer - Medical Device (Junior Level)

Planet Pharma; Lafayette (CO); On-site; USD 65,000 - 80,000; Full time

Job summary

Planet Pharma is searching for a junior level Test Engineer located in Lafayette, Colorado. This role involves key responsibilities including creating and performing verification & validation activities within an FDA regulated environment.

The ideal candidate will possess a strong foundation in software testing practices and experience utilizing AI tools to enhance their work efficiency. Candidates should hold a BS / BA in Engineering or Computer Science and have 1 to 2 years of relevant experience.

Qualifications

• 1-2+ years of experience with a Bachelor’s degree.
• Understanding of FDA Quality System Regulations (QSR) is a plus.
• Experience with medical device testing beneficial.

Responsibilities

• Responsible for plans, schedules and equipment required for testing.
• Perform verification and validation of new or changed products.
• Create, develop and maintain test software.

Skills

Knowledge of AAMI, ISO, FDA and EN standards

Software design, development, debug and test practices

Experience with AI tools for work efficiency

Oral and written communication skills

Ability to work in a team environment

Education

BS / BA in Engineering or Computer Science

Tools

AI coding tools (e.g., GitHub Copilot, Cursor)

Job description

Our client, a leading Medical Device company, is seeking a junior level Test Engineer with working knowledge software design, development, debug and test practices within an FDA regulated environment. This position has the responsibility and authority to create and perform verification & validation activities for software and systems to ensure the company's cutting-edge medical products meet our user’s needs and our quality and reliability standards. See below for other details!

Top Skills Needed

• Knowledge of applicable AAMI, ISO, FDA and EN standards or relevant work experience in a regulated environment
• Working knowledge of software design, development, debug and test practices.
• Experience utilizing AI tools to improve work efficiency, including writing and debugging test scripts, analyzing code or requirement changes, and streamlining documentation and reporting tasks

A Day in the Life

• Responsible for plans, schedules and equipment required for testing including tool/fixture/phantom design.
• Compiles data and defines changes required in test equipment, testing procedures, manufacturing processes, or new testing requirements.
• Frequent use and application of technical standards, principles, theories, concepts, and techniques.
• Responsible for verification and validation of new or changed products including generating plans, protocols and reports for testing performed.
• Create, develop and maintain test software.
• Ensures test equipment is in good working order and calibrated, as necessary.
• Coordinates and oversees the testing of equipment and product at outside test facilities.
• Sets up and develops test tracking, monitoring and data recording systems.
• Provides solutions to a variety of technical problems of moderate scope and complexity.
• Participate in all phases of product development as needed such as reviewing requirements, design, usability, risk assessment and defects.
• Design, implement and/or execute automated testing.
• Identify and implement process improvements.
• Participate in defect tracking and analysis.
• Troubleshoot, debug, maintain, and support existing products.
• Effectively communicate findings, problems and solutions to project teams and stakeholders.
• Collaborate and maintain excellent working relationships with team members and stakeholders.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.

Education Required

• BS / BA in Engineering or Computer Science

Years of Experience

• 1-2+ years of experience with a Bachelor’s degree

Specialized Knowledge Required

• Knowledge of applicable AAMI, ISO, FDA and EN standards
• Working knowledge of software design, development, debug and test practices.
• Oral and written communication skills.
• Ability to work in a team environment.
• Experience utilizing AI tools to improve work efficiency, including writing and debugging test scripts, analyzing code or requirement changes, and streamlining documentation and reporting tasks.

Nice to Have

• Experience with medical device testing and understanding of FDA Quality System Regulations (QSR)
• Able to handle multiple tasks/projects and manage priorities
• Experience with test automation including GUI, integration and stress testing and designing and implementing test automation frameworks, including AI-assisted coding tools (e.g., GitHub Copilot, Cursor, or similar)
• Ability to work in a fast paced, collaborative team environment.
• Experience with Agile and iterative development practices is a plus.
• Project management skills including planning, estimation, tracking and communication
• Self-motivated with strong problem-solving skills and the ability to work independently