Senior Quality Engineer (New Product Development) Quality
Location: San Diego, CA (On-site - 5 days per week) ***Please note must be located within commuting distance of San Diego, CA. ***
Employment Type: Full-Time
About the RoleAs 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 ResponsibilitiesDesign Quality & New Product Development- 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.
Design Transfer & Manufacturing Readiness- 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.
Operations & Supplier Quality- 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.
Quality Systems & Regulatory Support- 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.
CompensationThe 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
