Quality Process Engineer

Team info:

The new hire is going to be a part of the Quality Systems Team assisting Neuralink’s Research Services Org and engineering teams to perform process validations that include but are not limited to Sterilization Validation, Biocompatibility, Reprocessing Validations, Cleaning Validations, and Manufacturing Process validations.

Job Responsibilities:

• Develop creative testing pathways for flexible yet compliant validations.
• Assess changes to design or manufacturing processes, and how it impacts existing validations.
• Develop real-time dashboards for defect tracking, and implement process improvements.
• Be an excellent communicator who can clearly and effectively translate regulatory requirements into action.
• Have a clear understanding of how to apply risk assessments.
• Improve process efficiency for RSO to save time and automate multiple phases of the same process. Have advanced knowledge in the areas of Quality Assurance, Process Validation, Design Controls, Risk Management, and Statistical Techniques.
• Display excellent people skills.

Key qualifications:

• Undergraduate degree in an engineering discipline, OR currently pursuing a graduate degree in a STEM field. 
• Must have strong written and oral communication skills, and enjoy independent learning, doing research, and presenting on a wide variety of topics.
• A strong understanding of validations and engineering first principles. 
• Enjoys working in a collaborative environment with a mission first, go-getter attitude

Preferred qualifications:

Experience of 0-2 years in FDA-regulated industry (Medical Devices or Biotechnology)