Senior Quality Engineer-New Product Dev- CA

Job Description

Job Description

About Synchron

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.

Senior Quality Engineer (New Product Development)
Quality
Location: San Diego, CA (On-site)

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.

Key Responsibilities

• 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 during submissions by ensuring quality documentation is complete and inspection-ready.
• Participate in internal audits, supplier audits, FDA inspections, and Notified Body audits.
• Contribute to continuous improvement of Synchron’s Quality Management System.

Required Qualifications

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field
• 7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer.
• Experience supporting Class III medical devices preferred. CERTIFICATIONS

Preferred Qualifications

• ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred .
• Demonstrated knowledge of FDA Design Controls and product development processes.

• Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable product standards.
• Experience with Design Verification, Validation, Design Reviews, Design History Files, and traceability.
• Experience performing Design and Process FMEAs and applying risk management principles.
• Knowledge of process validation (IQ/OQ/PQ), manufacturing process development, and design transfer.
• Familiarity with supplier quality management and contract manufacturing.
• Ability to interpret engineering drawings, GD&T, and product specifications.
• Strong technical writing and documentation skills.
• Excellent communication and collaboration skills within multidisciplinary development teams.
• Ability to balance innovation with regulatory compliance in a fast-paced product development environment.

Compensation

The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications.

In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants , subject to board approval and company policy.

Visa Sponsorship

We are unable to offer visa sponsorship for this position currently.

Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible

• Subsidized medical and dental insurance coverage for you and your dependent(s)
• Life insurance, short-term disability, long-term disability
• 401k
• Discretionary unlimited PTO
• Flexible Spending Account for you and your dependent(s), with eligible plan elections
• Commuter benefits for NY employees

Equal Employment Opportunity (EEO)

Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.

If you need a reasonable accommodation during the application or interview process, please let us know.

Join Us

At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.