Summary of Major Responsibilities

The Systems Test Engineer I works with the systems development team to ensure that custom in vitro diagnostic systems meet design and customer requirements. The Systems Test Engineer I will use a technical background in software development and engineering, combined with an understanding of the system design, to analyze user needs, requirements, and specifications to assist in the creation of testing strategies and plans for verification and validation of the system designs.

Essential Duties and Responsibilities

• Follow all aspects of the software and product development lifecycles.
• Analyze user needs, software and hardware specifications, product requirements, and quality system requirements for moderate scope projects.
• Write and review design control documents, as needed.
• Assist in the design of testing strategies and detailed test plans for functional verification at module, unit, and system levels to ensure that product requirements, quality system requirements, regulatory requirements, and design specifications have been met.
• Apply general testing methodology based on black-box understanding of system function and specifications.
• Maintain and improve existing test assets.
• Assist in the investigation, reproduction, recording, and communication of software and hardware issues and defects.
• Review manuals and software documentation.
• Plan, schedule and execute test cases and record results and findings for systems of moderate scope.
• Identify and apply existing test tools.
• Assist with troubleshooting of system issues.
• Ability to work collaboratively in teams.
• Apply professional written and verbal communication skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• Ability to operate laboratory instruments and equipment, up to 8 hours per day.
• Ability to work in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.

Qualifications

Minimum Qualifications

• Bachelor's Degree in Engineering, Computer Science or field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience in lieu of Bachelor's degree.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Internship experience within a related field as outlined in the essential duties.
• Experience in an FDA-regulated environment, ideally in medical device development.
• Knowledge of regression, black box, white box, boundary condition, performance, and other standard testing strategies.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.