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:

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. You will help the nascent products in the pipeline efficiently complete medical-grade design and manufacturing processes and, by doing so, ensure the highest standard of product reliability and performance across the team.

Job Responsibilities:

• 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.
• 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 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 making any processes more efficient

Preferred Qualifications:

• 1+ years of experience with rigorous design control processes in safety-critical applications. (for example, in medical, automotive, aerospace, nuclear industries)
• 1+ years of experience working in a cleanroom production environment.
• Familiarity with hardware, software, and firmware development and production.
• Experience with medical device best practices and regulatory requirements for FDA and/or international bodies. For example, Design Controls, GMP, GCP.
• Track record of successfully implementing process improvements leading to increased efficiency and reliability.
• Experience with risk analysis.