Systems & Process Engineer

Posted 7 Days Ago
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Austin, TX, USA
In-Office
145K-165K Annually
Junior
Biotech
The Role
Gather systems requirements and develop compliant processes for medical device production. Improve process efficiency using Lean, SPC, DOE, and statistical analysis. Implement dashboards (Excel, Grafana, Google Sheets), manage deviations and audits, write SOPs, support validation and biocompatibility testing, and drive quality and throughput improvements.
Summary Generated by Built In

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.

To apply, please email your resume to [email protected]. Include job code 93277. Applications submitted through this form will not be considered.

Duties: 

Responsible for gathering systems requirements and developing processes with compliance in regulatory standards built into their design. Streamline operations and enhance process efficiency through innovative process development. Optimize and improve processes to eliminate variables, save time, and reduce costs to facilitate rapid iteration and innovation. Evaluate efficiency over time, moving from one method to another as they continue to be built and optimized. Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills. Assist with deviation and audit findings, track, ensure their effective execution, and coordinate timely closure of actions. Implement systems that drive compliance and optimize performance and recommend technical process changes to improve quality. Develop operational processes and communicate technical information to regulatory agencies. Develop quantifiable metrics displayed in real-time on a dashboard using relevant tools such as Excel, Grafana, and Google Sheets.

Education: Master’s or foreign equivalent in Chemical Engineering or related field

Experience: 2 years of experience in job offered or related occupation.

Special Requirements: Must have at least 1 year of prior work experience in each of the following:

  1. Performing Gauge R&R study and applying measures (e.g., Cp, Cpk) for process capability analysis and SPC methods for quality enhancement.
  2. Using Lean principles to drive continuous yield improvement. 
  3. Leading development of product characterizations and biocompatibility testing, DOEs, and validation protocols, leveraging statistical analysis (e.g., hypothesis testing, ANOVA) to drive data-driven decision-making.
  4. Leading development of strategic plans, aligning project goals, optimizing resource allocation, and implementing actionable strategies to drive improvements in quality, throughput efficiency, and market readiness 
  5. Performing system-level testing and implementing QC measures aligned with product specifications to uphold quality standards, while overseeing SOP documentation to ensure regulatory compliance. 

Salary: $145,000 - $165,000 USD

Worksite: Austin, TX

Applicant Instructions: Email resume to: [email protected]. Include job code 93277 in reply. EOE.

What We Offer:

Full-time employees are eligible for the following benefits listed below.

  • An opportunity to change the world and work with some of the smartest and 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
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) *Temporary Employees & Interns excluded
  • 401(k) plan *Interns initially excluded until they work 1,000 hours
  • Parental leave *Temporary Employees & Interns excluded
  • Flexible time off *Temporary Employees & Interns excluded

Skills Required

  • Master's degree in Chemical Engineering or related field (or foreign equivalent)
  • Minimum 2 years of experience in this job or related occupation
  • At least 1 year performing Gauge R&R and applying Cp/Cpk and SPC methods for process capability and quality improvement
  • At least 1 year using Lean principles to drive continuous yield improvement
  • At least 1 year leading product characterization, biocompatibility testing, DOEs, and validation protocols using statistical analysis (e.g., hypothesis testing, ANOVA)
  • At least 1 year leading development of strategic plans, aligning project goals and optimizing resource allocation to improve quality and throughput
  • At least 1 year performing system-level testing, implementing QC measures, and overseeing SOP documentation to ensure regulatory compliance
  • Experience developing real-time metrics and dashboards using tools such as Excel, Grafana, and Google Sheets
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The Company
HQ: Fremont, CA
367 Employees
Year Founded: 2016

What We Do

Neuralink is a team of exceptionally talented people. We are creating the future of brain-machine interfaces: building devices now that will help people with paralysis and inventing new technologies that will expand our abilities, our community, and our world. Our goal is to build a system with at least two orders of magnitude more communication channels (electrodes) than current clinically-approved devices. This system needs to be safe, it must have fully wireless communication through the skin, and it has to be ready for patients to take home and use on their own. Our device, called the Link, will be able to record from 1024 electrodes and is designed to meet these criteria.

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