Sr. R&D / Quality Engineer
NeuroBionics
About NeuroBionics
NeuroBionics, 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.
About the Role: Sr. R&D / Quality Engineer
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.
About 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
Duties and responsibilities
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 readiness
Proactively identify and close quality gaps
Qualifications:
Required:
Bachelor’s degree in engineering or technical discipline (required)
5+ years of hands-on experience in medical devices, ideally Class II or III
Experience with QMS, design control, and supplier quality
Proficient in test method development, root cause analysis, and risk management (FMEA, 5 Why, etc.)
Proficient with Minitab or similar tools for data analysis
Deep familiarity with ISO 13485, ISO 14971, FDA QSR, and relevant guidance documents
High attention to detail and rigorous documentation standards
Independent, proactive, and thrives in a fast-moving, startup environment
Preferred:
R&D engineering background in addition to quality experience — someone who has worked across both functions brings a meaningful advantage in a startup environment
Experience with Class III implantable or neuromodulation devices
Experience validating and managing sterilization
Experience with catheter, implantable, or minimally invasive device manufacturing
What we offer
What we offer:
Competitive and experience guided compensation with strong equity package
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Comprehensive benefits plan including
Health, dental and vision insurance covered at 100%
Health Reimbursement Account (HRA)
401(k) with company match
Parental & Medical Leave
Life and Long-term Disability insurance
Health & wellness benefit
3 weeks flexible PTO + 1.5 week company shutdown
Opportunity to learn and work for a fast-growing, VC-backed, MIT-spinoff on one of the most impactful problems that can change lives
Join us in shaping the future of neurotechnology!
Join NeuroBionics and contribute to the evolution of cutting-edge neural technology that has the potential to revolutionize bioelectronic medicine and improve the lives of countless individuals worldwide.