Quality Engineering Technician

About Neuralink:

We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed restore sight to the blind and revolutionize how humans interact with their digital world.

Team Description:

Join the Translational Team where we generate the data that advances Neuralinks braincomputer interface technologies from research and development through clinical evaluation and into market implementation. We produce the rigorous evidence required to support rapid development regulatory progress and the safe effective delivery of our technology to patients.

Job Description and Responsibilities:

The Quality Engineering Technician will execute and support equipment quality calibration maintenance troubleshooting verification and validation (V&V) and process and equipment qualification activities across R&D preclinical and manufacturing. Responsibilities include:

• Calibrate perform preventive maintenance troubleshoot and repair instruments devices and equipment in the quality program (including biomedical devices industrial instrumentation lasers RF systems and related technologies) with little to no supervision ensuring accuracy reliability and compliance.
• Assist in the check-out start-up installation acceptance and commissioning of new or modified equipment; support Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) activities; determine and requisition parts required for maintenance and repairs.
• Execute and document verification and validation activities for engineering work processes and equipment including following or supporting protocols collecting data recording results investigating deviations and maintaining traceability.
• Adhere to cGxP guidelines SOPs safety rules/regulations and quality system requirements; apply good documentation practices and clearly explain technical issues calibration processes and V&V/qualification results to cross-functional peers and stakeholders.
• Collaborate with engineering quality manufacturing and other teams to resolve equipment and quality issues support root-cause analysis and drive timely closure; contribute to continuous improvement of equipment quality processes procedures templates and workflows.
• Support change control and related quality activities for equipment and processes by providing accurate data documentation and technician-level input; maintain accurate equipment records and calibration status.
• Some travel may be required.

Required Qualifications:

• Ability to comprehend and apply technical manuals schematics and procedures for calibration maintenance troubleshooting testing and qualification activities.
• Strong attention to detail and ability to work accurately independently and effectively in a dynamic fast-paced regulated environment while managing multiple priorities.
• Strong interpersonal and communication skills; ability to collaborate professionally with cross-functional teams and explain technical issues clearly in an organized manner.
• Basic understanding of quality systems documentation practices and regulated (e.g. cGxP) environments.

Preferred Qualifications:

• Hands-on experience with calibration instrumentation preventive maintenance equipment troubleshooting or repair.
• Familiarity with biomedical equipment calibration preventive maintenance troubleshooting or repair.
• Experience supporting or executing verification and validation (V&V) activities process validations or equipment qualifications (IQ/OQ/PQ).
• Associates or Bachelors degree in Science Technology Engineering Mathematics or related field; or equivalent military training in calibration metrology instrumentation or electronics.
• Relevant experience working in highly regulated environments (e.g. GMP GCP GLP ISO 13485 medical device biotech or pharmaceutical settings).
• Familiarity with root-cause analysis techniques deviation management change control or continuous improvement of quality processes.
• Experience generating or executing test protocols recording data and contributing to calibration qualification or V&V reports and technical documentation.

Additional Requirements:

• Some travel may be required.

Expected Compensation:

At Neuralink your base pay is one part of your total compensation package. The anticipated hourly rate for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills experience and relevant education or training.

Hourly Range:
$26 $44/Hr USD