Software Engineer Jobot
Newport Beach, CA7 days ago
- $125,000–$140,000 Per Year
- Instant Apply
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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
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
#MS-OCENG
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.
- 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.
- 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.
- Bachelors or Masters 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.
- 35 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.
#MS-OCENG
Numbers & Facts
| Location | Cypress, CA |
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