Senior Design Process & Certification Engineer
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.
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 inventing new technologies that could expand our abilities, our community, and our world.
The ideal candidate is someone with a technical background who can grow the company’s design and manufacturing process and product reliability across the Robot, Surgery, and Brain Interfaces engineering teams, including pivotal contributions to future anomaly investigations and issue and risk systems.
From day one, you will be boots-on-the-ground with engineers in support of our first human surgeries. You will execute and improve design and manufacturing processes, learning the existing frameworks and building the trust of the engineering teams.
Then, you will leverage these skills to identify and address pain points across teams or departments, helping to solve them for the company as a whole. In this planned growth path, we would like you to evolve from supporting these tasks within a team, to defining and managing these solutions at cross-team/cross-department levels. This could include design and manufacturing process solutions, as well as potential issue and risk tracking and resolution.
In your first month:
- Support the progress of an engineering change, including progress toward verifications and validations, working closely with Quality Systems (QS) to understand any updates to validation requirements and working closely with design engineers on the change description and on the design transfer activities.
- Update the team’s general system docs for each block of changes (ex. each FDA supplement), such as the System Description, and “Intended Use, Normal Use, Essential Performance, and Reasonable Misuse”
- Help engineers execute the correct design transfer activities, and learn the system by doing. Manage the Design History File (DHF), DMR, DHR review, etc. for the team’s parts. Organize the official reviews; ensuring that document control & signature processes happen correctly. Create and release the “Design Transfer” elements like product BOMs, manufacturing procedures, tooling, and packaging (with support from design engineers as needed).
- Bridge between engineering design, manufacturing, and Quality Systems (QS). Work with QS to understand the current status of validations and adoptions and help designers select the correct validation strategies. Work with QS to help engineers make manufacturing workflows that maintain an extremely high standard for product safety and performance.
By your sixth month:
- Not only are you a local expert on these tools and processes from your early boots-on-the-ground work, but you have also implemented solutions that make them faster and more reliable for engineers to execute without you!
- You are the go-to person for ensuring reliability in the tools and processes we rely on to make safe and effective hardware, such as via the following examples:
- Drive improvements to the Change process, work instructions templates, drawing conventions, PLM workflow, and design process SOPs like part numbering schema.
- Drive (or manage the process for driving) design transfer and Phase Gate Reviews. Be point-of-contact for design-process-related support work, such as FDA interactions, tool improvements (working with QS and software infrastructure team), audit preparation.
- Improve systems for risk analysis, issue tracking
- Drive design process infrastructure for manufacturing, such as coordinating cross-company coherent implementations for receiving inspections or efficient scanning/tracking implementation.
- Drive anomaly investigations for cross-system anomalies, working closely with parties on other teams.
- You find large challenges exciting and enjoy discovering and defining problems as much as solving them.
- You deliver. You may enjoy thoughtful conversations about problems and perfecting designs, but in the end, you know that what matters is delivering a manufacturable solution that works every time.
- You are a cross-disciplinary team member. You are excited to work with and learn from software, mechanical, electrical, materials, biological engineers, and neuroscientists. You are comfortable communicating across teams.
- Resourceful, flexible and adaptable; no task is too big or too small.
- 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.
- 1+ years of experience with rigorous design control processes in safety-critical applications.
- 1+ years proven experience in organizing interdisciplinary teams to deliver product.
- Familiarity with hardware development and manufacturing
- 4+ years of experience with rigorous design control processes in safety-critical applications.
- 4+ years experience in organizing interdisciplinary teams to deliver product.
- Familiarity with hardware, software, and firmware development and production.
- Track record of successfully implementing process improvements leading to increased efficiency and reliability.
- Experience with risk analysis and issue tracking.
- Experience with cross-system anomaly investigations.
- Experience with medical device best practices and regulatory requirements for FDA and/or international bodies. For example, Design Controls, GMP, GCP.
- 1+ years of experience working in a cleanroom production environment.
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.