Company Description:
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.
Team Description:
Join our Quality Systems team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations.
Job Description & Responsibilities:
The Quality Engineering Intern will support the Quality Systems team in implementing and overseeing design controls. Their role involves evaluating, establishing, and maintaining effective Design Control disciplines to uphold compliance with FDA Part 820.30 and ISO 13485 standards within the quality systems. Furthermore, they will offer guidance, foster collaboration across departments to pinpoint areas for improvement, and demonstrate proactive involvement in addressing any identified Design Control (ISO-13485/CFR 820) gaps or remediation requirements.
- 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
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 design controls 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
- Experience of 0-1 year in Design Controls
Pay Transparency:
Based on California law, the following details are for California individuals only:
California Hourly Rate:
$28/hr USD
For Full-Time Employees, your compensation package will include two major components: salary and equity. Guidance on salary for this role will be determined according to the level at which you enter the organization, with the ability to gain more over time as you contribute. In addition, Full-Time Employees are eligible for the following benefits listed below.
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
- Paid holidays
- Commuter benefits
- Meals provided
- Equity + 401(k) plan *Temporary Employees & Interns excluded
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
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.
If you need a reasonable accommodation at any point in the interview process, please let us know. Reasonable accommodations are modifications or adjustments to the application or hiring process that would enable you to fully participate in those processes. Examples of reasonable accommodations include but are not limited to:
- Documents in alternate formats or read aloud to you
- Having interviews in an accessible location
- Being accompanied by a service dog
- Having a sign language interpreter present for the interview
