Quality Risk Engineer

Quality Systems   ·     Fremont, CA    ·    Full time

As a Quality Risk Engineer at Neuralink, you will be a part of the Quality Systems team responsible for managing and building a risk management program for Quality Assurance that covers but is not restricted to new products planning, design engineering, clinical functions, and process risk management. You are responsible for maintaining a strong collaborative partnership with cross-functional team members and ensuring that risk is appropriately mitigated, evaluated, disclosed, and monitored. 

Key Responsibilities:

• Responsible for supporting, developing, and executing risk management plan during the product development lifecycle.
• Responsible for supporting, developing, and executing manufacturing process-associated risk management plan.
• Be an excellent communicator who can clearly and effectively translate identified risks into clinical or design outcomes.
• Have a clear understanding of how to apply risk mitigation strategies.
• Support system hazard analysis and risk assessments (FTAs, and FMEAs)

Key Qualifications:

• Minimum BS degree; Minimum of  4 years of quality assurance experience.
• Very high energy and detail-oriented.
• Extremely good with people.
• Excellent creative problem-solving skills. 
• Excellent at putting plans into action.
• Working understanding of ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993 and ISO 13485.

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.
• Equity + 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.

Tagged as: BCI, Neuroscience