We are creating the future of brain-computer interfaces: building devices now that have the potential to help people with paralysis regain mobility and independence and invent new technologies that could expand our abilities, our community, and our world.
The new hire is going to be a part of the Quality Systems Team assisting in implementing and managing design controls. The Quality Engineering Intern is responsible for assessing, establishing, and maintaining effective Design Control disciplines to ensure alignment of FDA Part 820.30 and ISO 13485 standards within the quality systems. Provide guidance and collaborate across departments to identify gaps and show ownership with a hands-on approach in driving solutions to address any identified Design Control (ISO-13485/CFR 820) gaps or remediation needs.
- Review and assess DHF and Design Control records to ensure compliance with the state-of-the-art design control requirements per 21 CFR 820.30.
- Bring hands-on solutions and improvements to Design Control Records.
- Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance, and standards.
- Collaborate with cross-functional teams to address QMS noncompliance and develop remediation plans.
- Provide training and structure as needed for key Design Control (ISO 13485, CFR 820) elements.
- Generate, edit, and maintain QMS documentation, including but not limited to, departmental documents, procedures, work instructions, templates, and training materials including change control.
- Review verification and validation reports and identify gaps for compliance to internal quality requirements.
- 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 design controls and engineering first principles.
- Enjoys working in a collaborative environment with a mission first, go-getter attitude
- Experience of 0-2 years in FDA-regulated industry (Medical Devices or Biotechnology
- Experience of 0-1 year in Design Controls.
Based on California law, the following details are for California individuals only:
What we offer:
- 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; parental leave.
- Flexible time off + paid holidays.
- Equity + 401(k) plan.
- Commuter Benefits.
- Meals provided.
Multiple studies have found that a higher percentage of women and BIPOC candidates won't apply if they don't meet every listed qualification. Neuralink values candidates of all backgrounds. If you find yourself excited by our mission but you don't check every box in the description, we encourage you to apply anyway!
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.