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Solutions Engineer

Marquee Staffing

CA

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JOB DETAILS
SKILLS
Agile Programming Methodologies, Amazon Web Services (AWS), Change Control, Code of Federal Regulations, Cross-Functional, Documentation, Emerging Technology, Engineering, Failure Mode and Effects Analysis (FMEA), Hardware-Software Integration, ISO (International Organization for Standardization), Information Technology & Information Systems, International Electro-Technical Commission (IEC), Leadership, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Software, Manufacturing/Industrial Processes, Medical Equipment, Medical Organizations, Multitasking, Operations Processes, Process Manufacturing, Production Support, Project Development, Project Planning, Project/Program Management, Quality Assurance, Risk, Risk Analysis, Risk Management, Six Sigma, Software Administration, Software Development, Software Validation, System Integration (SI), System Operations, System Validation, Systems Engineering, Technical Leadership, Technical Strategy, Technical Writing, Traceability, User Interface/Experience (UI/UX), Validation Plan, Validation Testing
LOCATION
CA
POSTED
3 days ago
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.

 

About the Company

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Marquee Staffing

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