Sr. R&D​/Quality Engineer

About Neuro Bionics

Neuro Bionics, an MIT neurotechnology spinout, leads the way in developing implantable devices that interface with the human body to treat neurological conditions. Leveraging a decade of innovation, we have engineered a novel neural interface using microscale, flexible, bioelectronic fibers that seamlessly integrate with the human body. By making neural interfacing a minimally invasive procedure, we aim to revolutionize deep brain stimulation and broaden access to this life-changing therapy to millions of patients.

Location: Somerville, MA (On-site)

Experience: 5+ years in medical devices

We’re hiring a meticulous and versatile Sr. R&D / Quality Engineer to own and execute quality across our engineering, operations, and supplier workflows. You’ll work closely with our Director of Quality, who provides strategic oversight and mentorship on a part-time basis. Day-to-day, you’ll be the primary quality presence on-site—owning execution, driving decisions, and ensuring nothing slips through the cracks.

You’ll drive test method development, inspections, supplier quality, and QMS maintenance — while keeping documentation airtight and processes compliant. This is a cross-functional, high-trust role. You should be comfortable operating at the intersection of Quality Engineering (QE), Quality Assurance (QA), and Quality Control (QC), shifting from developing test methods and statistical analyses to inspecting supplier shipments and managing QMS documentation.

Important: We’re looking for candidates with a strong medical device background (Class II or III). Candidates from pharmaceutical or software quality backgrounds without direct device experience are unlikely to be a fit for this role.

This is an extraordinary opportunity to become a key member of an early-stage, VC-backed neurotechnology startup and help shape the future of our company. If you thrive in the details, work well independently, and have the grit to operate across the full quality stack, we’d love to meet you.

• Senior R&D or Quality engineer with 5+ years of hands-on experience in the medical device industry (Class II or III strongly preferred)

• R&D engineering background with strong quality instincts is a significant plus—someone who has worked across both functions brings a meaningful advantage in a startup environment

• Full startup experience, or big corporation with demonstrated ability to wear many hats and operate at every level

• Authorized to work in the United States - we are unable to provide visa sponsorship at this time

• Go-getter, fast and precise, with deep attention to detail

The Sr. R&D / Quality Engineer is responsible for the execution of QE/QA/QC activities across our development pipeline, ensuring rigorous product quality, robust documentation, and supplier accountability—all while supporting a culture of precision and compliance.

Test & Validation

• Design and validate test methods and tools

• Execute V&V activities and author protocols/reports

• Perform statistical analysis (Gage R&R, DOE) using Minitab or similar software

Manufacturing & Inspection

• Conduct incoming (AQL) receiving inspections, including label and packaging checks

• Supplier selection, qualification, inspection, and management

• Collaborate with R&D, manufacturing, and our suppliers on efficient and robust processes to evaluate product throughout the manufacturing and release

• Contribute to Design History File (DHF) including leading key activities regarding quality planning, Risk management (ISO 14971), and design verification testing

• Perform in-process and final inspections of final product, including DHR review

• Support investigations, root cause analysis, and CAPA implementation

• May perform sterilization review

Documentation & Process Control

• Manage hardcopy document control, traceability, and recordkeeping

• Maintain and improve the Quality Management System (QMS)

• Ensure compliance with ISO 13485, FDA QSR, and internal procedures

Cross-functional Execution

• Partner with engineering and operations to embed quality early

• Support design control activities, design transfer and product release…