Staff Manufacturing Engineer

About the role

We are seeking a Staff Manufacturing Engineer to lead the development and operation of our in-house pilot assembly line for our wearable robotics device. This role reports to the Robotics Manager and is responsible for establishing manufacturing processes, tooling, supplier relationships, and documentation.

Responsibilities

• Design, build, and bring up an in-house pilot assembly line for the wearable robotics device (end effector and actuation hardware).
• Own manufacturing readiness for Design Verification Testing (DVT) and early clinical builds, ensuring the line reliably produces units that meet design and quality requirements on schedule.
• Partner with R&D and design engineering to translate prototype and engineering-build processes into producible, repeatable manufacturing processes (design for manufacturability / design transfer).
• Partner with Quality to identify, evaluate, and qualify suppliers and vendors for components, subassemblies, and materials used in the glove and control unit.
• Manage ongoing supplier relationships, including quality issues, delivery performance, and cost/lead-time negotiations.
• Manage build technicians on the line, including setting priorities, scheduling, and day-to-day supervision of builds.
• Develop and maintain manufacturing documentation, including work instructions, process travelers, bills of materials, and equipment/tooling specifications.
• Support Device History Record (DHR) and Device Master Record (DMR) documentation in alignment with design controls.
• Ensure manufacturing processes and documentation comply with the quality management system (ISO 13485 and/or FDA 21 CFR 820, as applicable).
• Support process validation activities (IQ/OQ/PQ) as the line matures toward higher-volume production.
• Contribute to risk management activities for manufacturing processes.

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent hands-on experience.
• 7+ years of manufacturing engineering experience within the medical device industry.
• Direct, hands-on experience setting up a pilot or low-volume production line from scratch, including layout, tooling/fixture development, and process definition.
• Experience manufacturing Class II or Class III medical devices.
• Experience developing manufacturing documentation (work instructions, travelers, BOMs, DHR/DMR-related records) within a medical device quality system.
• Experience engaging with, qualifying, and managing suppliers/vendors for components or subassemblies.
• Experience supporting early-stage build phases such as DVT, EFS, or first-article/pilot builds.
• Comfortable operating in a small-company/startup environment with limited existing infrastructure — builds process rather than just following it.

Qualifications

• Preferred qualifications include experience with ISO 13485 and/or FDA 21 CFR 820 quality management systems, design-for-manufacturability (DFM), formal design transfer from R&D to production, electromechanical assemblies (mechanical, electrical, and/or soft-goods integration), process validation (IQ/OQ/PQ), and experience at an early-stage medtech or wearable robotics company.

Physical Requirements

• Ability to stand and move throughout a lab/production floor for extended periods;
• Frequent use of hands for fine-motor assembly tasks and hand tools;
• Sometimes lifting/carrying up to 25 lbs;
• Visual acuity sufficient for detailed assembly and inspection work, including under magnification when required.

Benefits

• Competitive base salary with equity;
• 100% of healthcare coverage for you and your dependents;
• Generous vacation policy;
• Paid parental leave;
• Work from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.

Compensation Range

$155K - $195K