Job Description

Job Title: Systems Engineer I

Job Type: Permanent

Location: Houston, TX (onsite)

A pioneering medical technology company developing a next-generation device are seeking a Systems Engineer to join their team. The company brings together a globally recognized team of engineers and experts. The original intellectual property was conceived by a biomedical innovator who remains actively involved in research partnerships. The company maintains strong partnerships with research institutions and industry leaders to push the boundaries of saving lives.

The systems engineer will play a key role within the engineering team, focusing on the verification and validation of all technical aspects of an implantable medical device. This role requires a high level of technical expertise to develop system specifications, design test methods, and conduct or oversee component, integration, and system-level testing.

The position involves conducting and documenting experiments to verify the device design, ensuring it consistently meets performance and design input specifications. Close collaboration with management and internal engineering teams will be essential to support the long-term development and viability of the product.

Responsibilities

• Define and specify requirements for component and system testing.
• Collaborate with multidisciplinary teams, including electrical, mechanical, and software engineering, to analyze product specifications.
• Develop system test specifications, feasibility assessments, and comprehensive verification and validation plans aligned with design requirements.
• Design and develop effective test facilities based on defined criteria.
• Lead the technical development of validation and verification test systems.
• Create test strategies, procedures, and cases to assess component and system performance against specified requirements.
• Apply cross-disciplinary engineering principles, standards, and techniques.
• Identify, design, install, and validate necessary testing equipment.
• Conduct and document experiments for product verification and validation.
• Plan, schedule, and coordinate validation and verification activities.
• Develop clear work instructions detailing testing processes.
• Ensure testing procedures are complete and consistent.
• Provide technical oversight and coordinate with technicians as needed.
• Support development, manufacturing, and compliance teams.
• Develop system models and simulations to evaluate performance and technical attributes.
• Participate in failure analysis and corrective action processes to guide design improvements.
• Assist in risk assessments, fault analysis, and regulatory documentation related to test plans and reports.

Requirements

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field.
• Advanced degrees (Master’s or PhD) are preferred.
• Familiarity with process characterization, risk analysis (e.g., pFMEAs), and validation methodologies such as IQ/OQ/PQ.
• Knowledge of regulatory and quality standards, including ISO 13485, ISO 9001, IEC 60601-1, and FDA quality regulations.
• Experience with component, integration, and system-level testing.
• At least one year of experience in medical device development.
• Project management and team leadership experience are advantageous.

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