Job Title: Systems Engineer

We are seeking a Systems Engineer to oversee how various components of a product work together across regulatory, quality, and R&D functions. This role involves managing and interpreting input requirements—including user needs, product specifications, and design constraints—while driving risk management and verification activities. The engineer will perform hands-on testing and support qualification, verification, and validation processes, including manufacturing test development. This position is critical in ensuring system-level integration and compliance, helping guide the product through its final stages to successful release.

• Manage and interpret input requirements such as user needs, product specifications, and design constraints.
• Drive risk management and verification activities.
• Perform hands-on testing and support qualification, verification, and validation processes.
• Develop manufacturing test processes.
• Ensure system-level integration and compliance.
• Guide the product through its final stages to successful release.

• Experience in medical device industry.
• Ability to align departments related to the product.
• Proficiency in risk management and risk verification.
• Hands-on testing skills.
• Experience with qualification, verification, and validation processes.

• Experience in regulated environments.
• in IVD and Diagnostics.

This position is based on-site in Santa Clara, offering a flexible start time between 7am to 9am, with an 8-hour shift. The facility is state-of-the-art, providing an excellent environment for developing innovative electronic products.