Senior Sustaining Systems Engineer

The Senior Sustaining Engineer I will provide hands-on technical support for manufacturing of commercialized medical devices. This role is focused on troubleshooting, process optimization, and ensuring reliable, compliant production. The role is part of the system team within product development and will partner closely with manufacturing, quality, and R&D to resolve issues, implement improvements, and sustain product performance throughout its lifecycle.

Responsibilities

• :Manufacturing Support: Serve as the primary technical resource from Systems Engineering to troubleshoot equipment and process issues
• .Sustaining Engineering: Maintain and improve existing manufacturing tools to ensure quality, yield, and efficiency
• .Root Cause Analysis: Lead investigations for nonconformances, deviations, and customer complaints; develop and implement corrective and preventive actions (CAPA) with respect to manufacturing tools and fixtures
• .Change Management: Prepare and execute engineering changes for documentation, tools and fixtures
• .Continuous Improvement: Identify and implement cost-reduction, reliability, and efficiency improvements using Lean and Six Sigma methodologies
• .Documentation: Generate and maintain manufacturing documentation such as work instructions, validation protocols/reports, and risk assessments
• .Cross-Functional Collaboration: Work on design transfer activities with Quality/Supply Chain on sustaining production needs
• .Manage fixture vendors and coordinate internal programming resources to ensure delivery of the fixtures meet design requirements, on budget and on schedule
• .Drive integration and troubleshooting for complex, multi-component system
• sDefine, execute and document system-level testing for Verification and Validation (V&V
• )Characterize process risks related to test fixture usage (PFMEA
• )Foster a close relationship with the Manufacturing team to develop a deep understanding of process, business and user needs (requires up to 30% travel

)
Requirement

• s:Bachelor’s degree in Electrical, Biomedical, or a related field (Master's degree or higher preferre
• d)Minimum 5 years of experience in sustaining or manufacturing engineering within the medical device industry (Class II or III preferre
• d)Hands-on experience with process validation, equipment troubleshooting, and production suppor
• t.Proficiency in root cause analysis tools (Fishbone, 5 Whys, FMEA) and statistical methods (SPC, DOE
• ).Excellent technical writing and documentation skill
• s.Ability to work independently on the production floor and collaborate across function
• s.Comfortable reading circuit board schematics and layo
• utFamiliarity with wireless (BLE, cellular, etc.) PCBA test systems a pl
• usEfficient and effective communication and collaboration skills; ability to synthesize information clearly and convey to other engineers (electrical, mechanical, software, manufacturing, etc
• .)Experience with medium to high volume manufacturing process and automated test fixtur
• esPrior experience in medical device development is highly desirabl

e.
Work Arrangem

• entHybrid role, based in our Cypress, California manufacturing and operations locat