Senior Systems Engineer

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

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

Work Environment

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.

Pay and Benefits

The pay range for this position is $49.00 - $65.00/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 Santa Clara,CA.

Application Deadline

This position is anticipated to close on Sep 16, 2025.