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Manufacturing Validation Engineer

Marquee Staffing
  • Cypress, CA
  • Instant Apply
2 days ago

Job Description

Position Summary
We are seeking a proactive, results-driven, and versatile Solutions Engineer to lead strategic technical initiatives across manufacturing operations in a fast-paced, digitally transforming medical device organization. This role sits at the intersection of engineering, digital systems, and operations, combining leadership in project management, requirements engineering, and software validation with a strong commitment to Lean, Agile, and Six Sigma principles to develop and deploy validated, scalable solutions.
Key Responsibilities
Systems Requirements & Engineering
  • Lead end-to-end execution of cross-functional operations and engineering projects from scoping and planning through deployment and post-launch support across multiple sites and functions.
  • Develop project plans, timelines, resource strategies, risk registers, and project documentation to deliver validated, audit-ready solutions.
  • Elicit and translate operational, business, and user requirements into functional and technical specifications.
  • Define architecture, interfaces, and integration points for new and legacy systems, including integrated hardware, software, and processes supporting manufacturing operations.
Risk & Compliance Management
  • Conduct and document technical risk assessments (e.g., FMEA, software risk) aligned with ISO 14971.
  • Ensure system implementations and changes meet ISO 13485, 21 CFR Part 820/11, and internal operating procedures.
Software Validation & Lifecycle Management
  • Develop and execute validation plans for non-product software used in manufacturing and quality processes.
  • Collaborate with IT, Systems, QA, and functional owners to ensure validated systems remain compliant through upgrades and change control.
Qualifications
  • Bachelor’s or Master’s degree in Engineering (Systems, Software, or another related technical field).
  • Experience developing AWS-based solutions and front-end and/or back-end software development is a plus.
  • 3–5 years of experience in a medical device manufacturing environment, operations engineering, or other regulated manufacturing environment.
  • Strong knowledge of ISO 14971, ISO 13485, 21 CFR Part 11/820, and IEC 62304.
  • Proven track record delivering validated systems that support production, traceability, and business/compliance objectives.
  • Demonstrated ability to thrive in rapidly evolving environments with shifting priorities and emerging technologies.
  • Ability to manage multiple priorities within demanding timeframes.
  • Direct experience in systems verification & validation (V&V) activities within the medical device industry.
  • Demonstrated experience in project planning, systems integration, and cross-functional technical leadership.


 

Numbers & Facts

LocationCypress, CA

Skills

  • Agile Programming Methodologiesunmatched
  • Amazon Web Services (AWS)unmatched
  • Change Controlunmatched
  • Code of Federal Regulationsunmatched
  • Cross-Functionalunmatched
  • Documentationunmatched
  • Emerging Technologyunmatched
  • Engineeringunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • Hardware-Software Integrationunmatched
  • ISO (International Organization for Standardization)unmatched
  • Information Technology & Information Systemsunmatched
  • International Electro-Technical Commission (IEC)unmatched
  • Leadershipunmatched
  • Lean Six Sigmaunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Softwareunmatched
  • Manufacturing/Industrial Processesunmatched
  • Medical Equipmentunmatched
  • Medical Organizationsunmatched
  • Multitaskingunmatched
  • Operations Processesunmatched
  • Process Manufacturingunmatched
  • Production Supportunmatched
  • Project Developmentunmatched
  • Project Planningunmatched
  • Project/Program Managementunmatched
  • Quality Assuranceunmatched
  • Riskunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Six Sigmaunmatched
  • Software Administrationunmatched
  • Software Developmentunmatched
  • Software Validationunmatched
  • System Integration (SI)unmatched
  • System Operationsunmatched
  • System Validationunmatched
  • Systems Engineeringunmatched
  • Technical Leadershipunmatched
  • Technical Strategyunmatched
  • Technical Writingunmatched
  • Traceabilityunmatched
  • User Interface/Experience (UI/UX)unmatched
  • Validation Planunmatched
  • Validation Testingunmatched

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