Equipment Quality Engineer

Regulatory    ·   Fremont, CA    ·   Full time

Neuralink is developing ultra-high bandwidth brain-machine interfaces to connect humans and computers. We are building a team of multidisciplinary experts passionate about making a world-changing impact.

As an Equipment Quality Engineer at Neuralink you will be responsible for the inspection, calibration, testing, maintenance and documentation of sophisticated medical, sterilization, and histopathology equipment. You will collaborate with multi-functional groups to resolve calibration/maintenance issues, support non-conformance investigations, improve equipment reliability, review procedures, and minimize equipment downtime.

About you:

• You find large challenges exciting and enjoy discovering and defining problems as much as solving them.
• You deliver. You may enjoy thoughtful conversations about problems and perfecting designs, but in the end, you know that what matters is delivering a manufacturable solution that works every time.
• You are a cross-disciplinary team member. You are excited to work with and learn from software, mechanical, electrical, materials, biological engineers, and neuroscientists. You are comfortable communicating across teams.
• Resourceful, flexible and adaptable; no task is too big or too small.

Essential responsibilities:

• Performs scheduled and unscheduled inspections, calibration, maintenance and electrical safety tests of biomedical equipment and medical systems where applicable to maintain code compliance.
• Develop and validate calibration procedures and measurement uncertainties for different kinds of electrical and electronic instruments and devices.
• Authorize and maintain metrological standards, policies and guidelines
• Review all equipment specifications and records information for completeness and appropriateness.
• Review and approval of Calibration, PM, and IQ/OQ/PQ documents and reports.
• Collect, report, review and maintain calibration and preventive maintenance performance data into LIMS (Laboratory Information Management System) .
• Manage service providers to ensure scheduling in accordance with Cal and PM due dates; coordinates the testing, monitoring, and inspecting processes of equipment calibration and PM
• Responsible for documenting the results of all inspections, maintenance and tests.
• Must work collaboratively with all tool users (surgery, veterinary medicine, and histopathology staff) and internal regulatory staff
• Occasional travel will be required to provide service support to other sites.

Qualifications:

• Evidence of exceptional ability in a technical discipline.
• 3+ years of hands-on experience in electronic instrument calibration method development, metrology and measurement techniques.
• Thorough knowledge of scientific principles required (general SOPs, GMP/GLP and ISO regulations)

What we offer:

• An opportunity to change the world and work with some of the smartest and the most talented experts from different fields.
• Growth potential. We rapidly advance team members who have an outsized impact.
• Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
• Flexible time off + paid holidays.
• 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.