Team Description:

Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.

We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.

Job Description and Responsibilities:

As a Quality Systems Engineer (dedicated towards Design Controls), your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.

You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.

You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)
• Develop and maintain end-to-end traceability frameworks linking:
• User needs
• Software requirements
• Risk controls
• Design outputs (code, architecture)
• Verification and validation evidence
• Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
• Build change control mechanisms capable of supporting:
• Rapid iteration
• Parallel development
• Same-day deployment
• Partner closely with software engineering teams to embed:
• Compliance with CI/CD pipelines
• Automated evidence generation
• Controlled release processes
• Own subsets of the Quality System related to software design controls, including but not limited to:
• Software Design Control processes
• Software Risk Management
• Software Change Control
• Software Verification & Validation traceability

Required Qualifications: 

• Bachelor’s degree in Electrical Engineering, Computer Science, or a related technical field
• Demonstrated experience designing or maintaining structured engineering or compliance systems
• Familiarity with software development lifecycles in regulated or safety-critical environments
• Working knowledge of:
• Design Controls
• Software requirements management
• Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)
• Excellent written and verbal communication skills
• Strong problem-solving mindset with the ability to think in systems rather than silos

Preferred Qualifications:

• Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes)
• Familiarity with FDA Design Controls (21 CFR 820.30)
• Familiarity with Design Risk Management (ISO 14971 principles)
• 1–3 years of experience in:
  • Design Controls
  • Software Quality
  • Regulated software development

Team Description:

Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.

We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.

Job Description and Responsibilities:

Please note, this is a duplicate posting for the "Quality Systems Engineer" role. We are testing titling to see which attracts the most qualified candidates. Please only apply to one of the postings. 

As a Design Controls Engineer, your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.

You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.

You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)
• Develop and maintain end-to-end traceability frameworks linking:
• User needs
• Software requirements
• Risk controls
• Design outputs (code, architecture)
• Verification and validation evidence
• Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
• Build change control mechanisms capable of supporting:
• Rapid iteration
• Parallel development
• Same-day deployment
• Partner closely with software engineering teams to embed:
• Compliance with CI/CD pipelines
• Automated evidence generation
• Controlled release processes
• Own subsets of the Quality System related to software design controls, including but not limited to:
• Software Design Control processes
• Software Risk Management
• Software Change Control
• Software Verification & Validation traceability

Required Qualifications: 

• Bachelor’s degree in Electrical Engineering, Computer Science, or a related technical field
• Demonstrated experience designing or maintaining structured engineering or compliance systems
• Familiarity with software development lifecycles in regulated or safety-critical environments
• Working knowledge of:
• Design Controls
• Software requirements management
• Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)
• Excellent written and verbal communication skills
• Strong problem-solving mindset with the ability to think in systems rather than silos

Preferred Qualifications:

• Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes)
• Familiarity with FDA Design Controls (21 CFR 820.30)
• Familiarity with Design Risk Management (ISO 14971 principles)
• 1–3 years of experience in:
  • Design Controls
  • Software Quality
  • Regulated software development

Team Description:

Join the Quality Team at Neuralink, a group of dedicated professionals building and sustaining world-class quality and compliance frameworks from the group up. The Quality team focuses on exceeding regulatory requirements and industry best practices to enable safe and fast development of Neuralink’s innovative technologies.

Job Description and Responsibilities:

Neuralink is seeking a Document Control Specialist with strong organization skills to support document control-related activities company-wide. This role will serve as a foundational resource for organizing and managing critical documentation across the preclinical, manufacturing, engineering, quality, and regulatory departments. This position will support the maintenance, development, and scaling of processes, archiving, and compliance tracking—ensuring traceability, version control, and readiness for audits and submissions in a highly regulated environment.  Additionally, you will be expected to:

• Sustain and improve document control systems across Neuralink in alignment with FDA regulations (e.g., 21 CFR Part 11, 21 CFR 58, 21 CFR 812) and other GxP requirements
• Organize GxP files (including study records, lab data, equipment logs, and audit documentation) into a traceable, trackable, and searchable system
• Maintain archives for GxP studies and ensure proper retention, deprecation, and re-indexing as needed (including leading archive re-indexing projects to correct/improve indexing)
• Assist in SOP development, revisions, periodic reviews, and maintenance of tables of contents
• Assist with the maintenance of various study trackers, training assignments, master schedule(s), and the glossary
• Facilitate the completion of deviations and  investigations
• Manage document lifecycles: versioning, deprecation of obsolete documents, and routing/approval workflows
• Support the Regulatory department by organizing regulatory filings (e.g., new study submissions and supplements), managing uploads to the eTMF, and preparing routine submission documents (cover letters, annual reports)

Required Qualifications:

• Meticulous attention to detail and exceptional organizational skills
• Excellent verbal and written communication skills
• Strong multitasking abilities in a dynamic, fast-paced, and constantly changing environment
• Proficiency with Google Suite (Docs, Sheets, etc.) and standard document management tools
• Working knowledge of medical, scientific, and regulatory terminology

Preferred Qualifications:

• Bachelor's Degree in a relevant field, such as life sciences, engineering, technical writing/communications, regulatory affairs, or equivalent
• Relevant experience working in highly regulated environments, such as the medical device or pharmaceutical industries

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.

Texas Hourly Range:

$21 – $35/Hr USD

Team Description:

Join our innovative Equipment Quality Team, a dynamic collective of experts dedicated to maintaining the precision and efficacy of high-tech equipment in preclinical and manufacturing domains. Engage with the latest in biomedical devices, industrial instrumentation, and high-end technologies like lasers and RF systems. As pioneers who've crafted a robust equipment program from scratch, we champion creative problem-solving and strive to set industry benchmarks. Immerse yourself in a mission-critical role that propels safety and regulatory compliance to new heights, and become part of a collaborative force driving the future of biomedical quality.

Job Description and Responsibilities:

Neuralink is seeking an Equipment Quality Technician with a strong knowledge of applied metrology. This technician will calibrate, repair, and perform preventative maintenance on equipment in the quality program. In addition, they will troubleshoot and repair instruments and systems. This role requires participation in cross-functional teams and some travel. Additionally, you will be expected to:

• Calibrate and perform preventive maintenance on any instrument or device in the equipment quality program with little to no supervision
• Provide the technical expertise for assisting management in developing work procedures and protocols
• Assist in the design, fabrication, check-out, start-up, and acceptance of new or modified equipment
• Determine and requisition parts required for maintenance repairs
• Adhere to cGxP guidelines, SOPs, and safety rules/regulations
• Assist management with determining work schedules and project costs
• Work closely with cross-functional team members  in regards to continuous improvement activities, solving problems, and improving overall product quality
• Explain calibration issues and processes to equipment custodians and management

Required Qualifications:

• Ability to comprehend and apply manuals and schematics for maintenance and troubleshooting
• Proficiency in using hand tools, physical/dimensional test instruments, and electronic test instruments
• Able to work in a dynamic, fast-paced environment
• Strong interpersonal skills: ability to work with colleagues and cross-functional teams in a professional and organized manner
• Competence in operating computing hardware and standard software
• Minimum of 1 year of experience related industrial instrumentation/calibration experience and/or training; or equivalent combination of education and experience
• Willingness to assist with other Quality Engineering activities such as facilities, equipment, and facilities validation

Preferred Qualifications:

• Experience in PMEL, TMDE, Metrology, Calibration, Instrumentation, Validation, or Biomedical Equipment
• Associates or Bachelors Degree in Science, Technology, Engineering, Mathematics or military training in calibration
• Relevant experience working in a highly regulated (e.g., GMP, GCP, GLP) environments