Senior System Test Engineer – Medical Device Verification

TAE Life Sciences U.S. LLC; Irvine (CA); On-site; USD 140,000 - 165,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(K) with company match

Paid vacation + sick time

Parental leave

Wellness program

Equity participation

Job summary

TAE Life Sciences, Irvine, seeks a System Test Engineer to verify and validate complex medical device systems within the Quality organization. You will develop and execute test cases supporting Design Verification, Design Validation, and Usability Engineering, working with Systems, Hardware, and Software teams as well as Clinical staff.

Ideal candidates have 5+ years in system-level verification of regulated devices, strong problem-solving and technical writing skills, and a proactive approach

Qualifications

• Strong analytical and problem-solving skills with attention to detail.
• Ability to critically evaluate requirements for completeness and testability.
• Excellent writing skills for technical test cases.
• Experience with hardware, software, and electromechanical subsystems.
• Ability to collaborate with cross-functional teams.
• Experience with complex computer-controlled systems.

Responsibilities

• Develop and maintain verification and validation strategies and plans.
• Create and maintain plans for Design Verification, Design Validation, and Usability.
• Review architecture, requirements, and design documents.
• Derive effective test cases to verify requirements and user needs.
• Execute test cases and record results accurately.
• Identify and document defects with reproducibility details.
• Maintain traceability between requirements, tests, and risks.
• Adhere to SOPs and Quality Management System.
• Collaborate with development to meet Design Controls needs.
• Represent QA in meetings and design reviews.

Skills

Analytical thinking

Requirements analysis

Technical problem solving

Technical writing

Cross-functional collaboration

Complex systems experience

Education

Bachelor’s degree (BS) in Engineering/Computer Science/Other Technical Discipline

Job description

TAE Life Sciences, Irvine, seeks a System Test Engineer to verify and validate complex medical device systems within the Quality organization. You will develop and execute test cases supporting Design Verification, Design Validation, and Usability Engineering, working with Systems, Hardware, and Software teams as well as Clinical staff.

Ideal candidates have 5+ years in system-level verification of regulated devices, strong problem-solving and technical writing skills, and a proactive approach