Medical Tester

ITJ; México; Presencial; MXN 1.260.579 - 1.620.745; Jornada completa

Descripción de la vacante

A leading medical device company is seeking a Senior Systems Verification Engineer to work with a development team on integration and testing of In Vitro Diagnostic products. The role includes developing project requirements, participating in design reviews, and creating test plans. Candidates should have a BS/BA degree in a relevant field and at least seven years of experience, ideally in the medical device sector. This full-time position is suitable for individuals with strong communication and organizational skills.

Formación

• Minimum of seven (7) years of previous experience required, preferably in medical device industry.
• Experience in the full development lifecycle for product delivery to market of at least one product required.

Responsabilidades

• Assist with the development of project requirements and support tracing of design inputs to design outputs.
• Participate in design reviews, develop test automation solutions, and create test plans, test cases, and reports.
• Develop verification planning documentation for development projects as needed.
• Analyze requirements and design specifications from a systems perspective.
• Develop strategies for system-level product testing.
• Create work breakdown schedule estimates and execute test plans and procedures.
• Assist with system integration and debugging as needed.

Conocimientos

Testing experience in medical device development or other regulated industry

Experience in elicitation, writing and traceability of system/subsystem requirements

Experience designing and/or creating and utilizing test bench components

Broad technical understanding of multiple disciplines

Familiarity with reliability testing

Good communication and presentation skills

Strong planning and organizational skills

Educación

BS/BA degree in CS, EE, ME, Biomedical or related Engineering discipline

Descripción del empleo

The Senior Systems Verification Engineer will work with the Development team in the system integration and testing of our In Vitro Diagnostic (IVD) products. The Senior Systems Verification Engineer may provide mentorship to other Verification Engineers, and typically works closely with other team members in the system integration and testing of our medical devices.

Key Accountabilities

• Assist with the development of project requirements, support tracing of design inputs to design outputs.
• Participate in design reviews, develop test automation solutions, and create test plans, test cases, reports, and other deliverables with possible interaction with clinicians, third‑party vendors, manufacturers, and others.
• Develop verification planning documentation for development projects as needed.
• Analyze requirements and design specifications from a systems perspective.
• Develop strategies for system‑level product testing, including software, electrical, analytic, and/or mechanical aspects of the system.
• Develop system and subsystem test procedures based on product and/or subsystem requirements.
• Develop test automation and/or test bench component solutions in support of functional and reliability testing with detailed documentation.
• Participate in hazard and risk analysis.
• Support design activities and attend design reviews.
• Create verification reports and overall verification summary reports for systems verification activities.
• Create work breakdown schedule estimates.
• Create and execute test plans and procedures.
• Assist with system integration and debugging as needed.
• Operate electrical, mechanical, and digital equipment and test fixtures.
• Work well in a team.
• May participate in interviews for new department personnel as necessary.
• May work on process improvement activities.
• Other duties as assigned with or without accommodation.

Networking/Key relationships

• Research and Development
• Quality Engineering

Minimum Knowledge & Experience required for the position

• BS/BA degree in CS, EE, ME, Biomedical or related Engineering discipline required.
• Minimum of seven (7) years of previous experience required; medical device industry experience preferred.
• Experience in the full development lifecycle for product delivery to market of at least one product required.

Skills & Capabilities

• Testing experience in medical device development or other regulated industry is desired.
• Experience in elicitation, writing and traceability of system/subsystem requirements for product development is desired.
• Experience designing and/or creating and utilizing test bench components for system/components testing is desired.
• Broad technical understanding of multiple disciplines from electrical, mechanical, software is desired.
• Familiarity with reliability testing is desired.
• Good communication and presentation skills.
• Strong planning and organizational skills required.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Information Technology & Services and Medical Equipment Manufacturing