Sr. R&D / Quality Engineer

NeuroBionics•Somerville, MA

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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
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

Benefits

Competitive and experience guided compensation with strong equity package
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