Senior Quality Engineer- Product Dev- CA

Senior Quality Engineer (New Product Development)

Synchron's vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time.

In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems.

Quality

Location:

San Diego, CA (On-site)
*** Please note must be located within commuting distance of San Diego, CA. ***

Employment Type:

Full-Time

About the Role

As Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron's product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. You will lead Design Quality activities, ensure compliance with FDA, ISO 13485, ISO 14971, and applicable international regulations, and facilitate successful transfer of new products into manufacturing.

You will also provide operational quality support during pilot builds and early production while contributing to the development and continuous improvement of Synchron's Quality Management System.

• Serve as the Quality representative on cross-functional product development teams from concept through commercialization.
• Ensure compliance with Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulations.
• Lead Design Quality deliverables including:
• Design Reviews
• Design Verification & Validation (V&V)
• Design History File (DHF) development
• Traceability
• Engineering Change Assessments
• Facilitate product risk management activities in accordance with ISO 14971, including hazard analyses, risk assessments, FMEAs, and verification of risk controls.
• Review and approve product requirements, specifications, protocols, reports, drawings, and engineering documentation to ensure quality and regulatory compliance.
• Collaborate with engineering teams to establish critical quality attributes, acceptance criteria, and design inputs/outputs.
• Drive Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Quality (DFQ) principles throughout development.

• Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits.

• Partner with R&D and Manufacturing Engineering to execute successful design transfer into production.
• Develop manufacturing quality strategies including Process FMEAs, Control Plans, inspection strategies, and manufacturing quality gates.
• Support process validation activities (IQ/OQ/PQ), equipment qualification, and pilot manufacturing builds.
• Evaluate manufacturing readiness and identify quality risks prior to product launch.
• Support engineering changes through impact assessments and change control activities.

• Collaborate with Operations and Supplier Quality to qualify suppliers and contract manufacturers supporting new product development.
• Review supplier validation activities, incoming inspection strategies, and quality documentation.
• Support investigations involving nonconforming materials, manufacturing deviations, and CAPAs associated with prototype and pilot production.
• Monitor quality metrics during new product introduction (NPI) and drive continuous improvement initiatives.

• Author and maintain Design Quality documentation including:
• Design Plans
• DHFs
• Risk Management Files
• SOPs
• Quality Plans
• Verification & Validation protocols and reports
• Support Regulatory Affairs…