Quality Assurance Engineer

Company Overview

BrainRobotics is a scale-up innovator in the prosthetics industry, dedicated to enhancing lives through cutting-edge bionic solutions. With a commitment to innovation, compassion, and accessibility, we strive to ignite the human spirit through advances in bionic mobility.

Position Overview

We are seeking a detail-oriented Quality Assurance Engineer to support our prosthetic technologies by ensuring compliance with global quality standards and FDA regulations. This role is ideal for a proactive problem-solver with a background in medical device engineering who thrives in a fast-paced startup culture. You will bridge the gap between engineering and quality assurance, overseeing the Quality Management System (QMS) while participating in hands-on product validation and root-cause investigations.

Key Responsibilities

- Quality System Management:
Assist in the development and maintenance of the QMS, including the creation and update of Standard Operating Procedures (SOPs) and Work Instructions to ensure alignment with FDA regulations.
- Verification & Validation:
Execute technical quality procedures and validation protocols for FDA Class I medical devices, including hardware, firmware, and software applications. Assist in developing test cases to verify that prosthetic devices meet engineering specifications and user needs.
- Product Performance:
Support root-cause investigations into technical issues and escalated field events; manage Corrective and Preventive Action (CAPA) activities and tracking. Monitor quality metrics and prepare data-driven reports (NCR, CAPA, supplier performance) to help leadership identify areas for process improvement.
- Inspections & Documentation:
Perform incoming inspections, MRB activities, and Device History Record (DHR) reviews. Manage Engineering Change Orders (ECO/DCO) process to ensure technical changes are documented and approved.
- Cross-Functional Collaboration:
Partner with R&D, manufacturing and quality teams to ensure all product updates and new releases meet strict performance and documentation criteria prior to launch, while performing additional duties as assigned by management to support departmental goals.

Qualifications

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or a related technical field from an ABET-accredited program.
• 1–2 years of hands-on experience in quality engineering or quality assurance within the medical device industry (Class I or II preferred).
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, and QMSR. Familiarity with hardware/software validation and risk management reports.
• Excellent written and verbal skills, with the ability to document technical work clearly and influence cross-functional teams.
• Proven ability to juggle multiple priorities and release deadlines in a fast-paced environment without compromising safety or quality.

Preferred Qualifications

• ASQ (CQE/CQT) or Six Sigma Green Belt certification.
• Working knowledge of prosthetic/orthotic devices or clinical vocabulary.
• Familiarity with CI/CD practices for firmware/software testing and Agile/Scrum frameworks.
• Previous experience in a startup or high-growth "scale-up" environment.

Join Us

If you are passionate about advancing prosthetic technology and possess the expertise to bridge the gap between engineering innovation and patient-centered product solutions, we invite you to apply to join the BrainRobotics team.

BrainRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. BrainRobotics makes hiring decisions based solely on qualifications, merit, and business needs at the time.