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Quality Risk/Design Engineer

Employer
Neuralink
Location
Fremont, CA
Start date
Jul 21, 2022
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As a Quality Risk/Design 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. Please note that this is not an entry-level position.

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).

Qualifications:

  • Minimum BS degree; Minimum of 4 years of quality assurance experience.
  • Very high energy and detail-oriented.
  • Extremely good with people.
  • 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.
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