Software Test Engineer
Job
Actalent
Irvine, CA (In Person)
$145,600 Salary, Full-Time
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Job Description
Job Title:
Software Test Engineer Job Description The Software Test Engineer develops, documents, executes, and maintains software verification procedures, testing tools, and traceability to support the development of complex medical device products in accordance with regulatory requirements. This role focuses primarily on manual testing of Class III medical devices, contributing directly to the safety and effectiveness of life-saving emergency care technologies within a structured, design-controlled environment. Responsibilities Develop, document, review, and maintain high-quality software verification procedures that comply with applicable regulatory and quality standards. Analyze software requirements and design comprehensive verification tests that ensure full coverage of functional and non-functional requirements. Create new test cases and update existing test protocols to validate software requirements for complex medical device systems. Execute manual verification test procedures for complex medical devices and accurately document test results and defects. Plan or assist in planning verification activities for software projects, including providing effort estimates and schedules for testing tasks. Participate in all phases of the software development life cycle, with a focus on maintaining test protocols and requirements traceability. Perform software integration testing for software-to-software and software-to-hardware subsystems to ensure proper interaction and system behavior. Track and report progress toward performance, quality, and schedule objectives, escalating issues and risks as appropriate. Create or specify software and hardware tools, fixtures, and test setups required to support efficient and reliable software testing. Use bug tracking and application lifecycle management tools to log, track, and manage defects and test activities. Follow standard operating procedures, design controls, and software test engineering best practices in a regulated environment. Collaborate closely with software testers, developers, and cross-functional team members to deliver high-quality solutions. Contribute to a positive, collaborative team environment focused on continuous improvement and product quality. Essential Skills Minimum of 3 years of experience in manual software testing. Hands-on experience with software testing in a structured development environment with design controls. Experience using bug tracking and software development lifecycle tools, with Jira strongly preferred. Knowledge of IEC standards relevant to software and medical devices. Background in medical device software testing, particularly in regulated environments. Experience with validation activities for software in a regulated or medical device context. Familiarity with Scrum or agile development methodologies. Ability to perform software integration testing for software and hardware subsystems. Strong documentation skills for creating and maintaining test procedures, protocols, and traceability. Ability to work effectively as an individual contributor while collaborating closely with a larger test team. Additional Skills & Qualifications Experience working with Class III medical devices. Experience with ventilator systems or similar life-support medical devices. Experience with Perforce Helix ALM or similar application lifecycle management tools. Experience with Perforce Helix for version control is a plus. Prior experience in an agile Scrum environment is a plus. Interest in and commitment to working on life-saving emergency care products. Understanding of design control processes in regulated product development. Familiarity with innovative medical technologies and their regulatory constraints. Work Environment The role operates in a collaborative, structured environment focused on the development and testing of Class III medical devices. The Software Test Engineer works as an individual contributor while engaging closely with a team of software testers and cross-functional stakeholders. Work involves extensive manual testing, use of software lifecycle tools such as Jira and Perforce Helix, and adherence to design controls and IEC standards. The environment emphasizes innovation, regulatory compliance, and high product quality, with a strong mission-driven culture centered on developing life-saving emergency care products. Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits The pay range for this position is $60.00 - $80.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine,CA.
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