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Company

Original Job Post

Neuralink · 3 days ago

Design Assurance Engineer

Fremont, CA

Full-time

Onsite

Entry, Mid Level

$103K/yr - $229K/yr

2+ years exp

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Responsibilities

Ensure compliance with customer, risk management, quality, and design control requirements in design and development projects

Support successful transfer of designs to manufacturing

Participate in decisions on scope of work, material selection, design reviews, and design changes

Develop, apply, revise, and maintain quality and regulatory standards for medical device products

Inspect, test, and evaluate product accuracy and precision

Diagnose and resolve manufacturing and quality system issues

Perform design reviews and pre-validation assessments

Generate and maintain risk management files for product development

Provide guidance on statistical analysis and process optimization

Follow safety and production procedures

Design processes for efficiency and rapid iterations

Collaborate with cross-disciplinary teams

Deliver efficient solutions and problem-solving

Communicate effectively across teams

Be resourceful, flexible, and adaptable

Qualification

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Engineering PrinciplesProcess ScalabilityProblem-SolvingCommunicationAttention to DetailDesign Control ProcessesRisk ManagementRegulatory RequirementsFDAGMPGCP

Required

Bachelor's Degree in science or engineering, or equivalent in experience and ability.

Strong understanding of engineering first principles.

Excellent verbal and written communication.

Relentless attention to quality.

Experience building processes that are scalable.

Preferred

2+ years of experience with rigorous design control processes in the medical device industry.

1+ years of experience working in risk management.

Experience with medical device best practices and regulatory requirements for FDA and/or international bodies. For example, Design Controls, GMP, GCP.

Benefits

Excellent medical, dental, and vision insurance through a PPO plan

Paid holidays

Commuter benefits

Meals provided

Equity + 401(k) plan

Parental leave (Temporary Employees & Interns excluded)

Flexible time off (Temporary Employees & Interns excluded)

Company

Neuralink

Glassdoor

3.9

Neuralink develops a brain machine interface that provides solutions for those with paralysis.

Founded in 2016

Fremont, California, USA

201-500 employees

https://www.neuralink.com

H1B Sponsorship

Neuralink has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (2)

2022 (5)

2021 (8)

2020 (5)