Team 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 inventing new technologies that could expand our abilities, our community, and our world.

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 transfer and manufacturing processes, learning the existing frameworks and building the trust of the engineering teams. The ideal candidate is someone with a technical background with strong writing skills, with the ability to parse important details from ambiguity, and who is comfortable working alongside design engineers and manufacturing lines. Through your ownership of critical design and manufacturing documentation outputs, you will help ensure the highest standard of product reliability and performance across the team.

Job Responsibilities and Description:

You will:

• Deliver coherent, efficient outputs that exhibit extraordinary attention to detail in both technical and grammatical accuracy.
• Support the progress of an engineering change, including progress toward verifications and validations, working closely with Quality Systems (QS) and design engineers on the change description documents and on the design transfer activities.
• Update the engineering team’s general system documents 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. For example, manage the completion of the DMR (Device Master Record) and organize the official reviews, ensuring that document control & signature processes happen correctly. Create and release the “Design Transfer” elements like product BOMs and manufacturing procedures (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. Update manufacturing work instructions to maintain an extremely high standard for product safety and performance.
• As you learn the pain points, implement solutions that make these processes faster and more reliable for engineers to execute.

About You:

• 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.

Key Qualifications:

• Bachelor’s Degree in a technical field, or equivalent in experience and ability.
• Strong understanding of basic physics first principles.
• Excellent verbal and written communication.
• Relentless attention to quality.
• Experience making any processes more efficient

Preferred Qualifications:

• Authored articles published in peer-reviewed journals.
• Track record of successfully implementing process improvements leading to increased efficiency and reliability.
• Familiarity with hardware, software, and firmware development and production.
• 1+ years of experience with design or production processes for safety-critical applications. (for example, in medical, automotive, aerospace, nuclear industries)
• Experience with risk analysis