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

Job Description:

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.

Job Responsibilities:

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.

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 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

Preferred qualifications:

• 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.