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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Systems Engineer - **Company:** Diality Inc - **Location:** Irvine, CA, United States - **Experience:** Expert - **Salary:** $120,000.0 - $133,000.0 - **Contract:** Permanent contract - **Skills:** Systems Engineering, SolidWorks (CAD), Failure Mode Effects Analysis, Python (Programming Language), MATLAB, Minitab, Software Tools, Requirements Management, Software Engineering, Verification and Validation (Software), Systems Architecture, Scripting - **Published:** July 18, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=9766827a7ec990fc ## About the Role * Expert knowledge on medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance. * Proficiency in engineering tools (e.g., SolidWorks, Minitab). * Demonstrated proficiency in scripting languages (e.g. Python, MATLAB) and other software languages. * Strong problem-solving skills with the ability to conceptualize and develop innovative engineering solutions to complex technical challenges. * Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization. * Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance., * Bachelor's degree in biomedical, electrical, mechanical, systems or software engineering. * Minimum 5 years of related experience or 3 years and a Master's degree in engineering. * Solid systems engineering experience across the entire product lifecycle, with proficiency in tools such as requirements management, change control, traceability analysis etc. * Strong experience in risk management methodologies (e.g., FMEA, fault tree analysis) and their application to medical device development and regulatory compliance. * Strong experience in managing product and subsystem-level requirements throughout the development process. * Experience in conducting design verification and validation activities, including protocol development, testing, and documentation, in accordance with regulatory requirements. * Experience in system architecture design and control system design. * Has experience in system architecture design and control system design. Travel * N/a Physical Requirements * Prolonged periods of sitting at a desk and working on a computer. * Must be able to lift up to 15 pounds at times. * Must be able to access all areas of the facility to determine needs. ## Description As a Senior Systems Engineer, you will leverage your extensive expertise to drive the design, development, and validation of complex systems, ensuring compliance with regulatory standards and industry best practices., * Lead cross-functional team through the design control process. * Complete DHF documentation deliverables including - Product Requirement Specification, System Architecture Document, System Hazard Analysis, Failure Modes and Effects Analysis * Collaborates with stakeholders to decompose User Need requirements into product level and subsystem level requirements. * Lead the risk management process in compliance with ISO 14971 * Strategizes and develops verification and validation test plans to ensure product requirement specifications are met. Coordinates testing activities with internal teams and external partners to ensure V&V testing deliverables are met. * Develops and validates test methods to appropriately verify product level requirements. * Actively performs system level verification testing to ensure systems meet product level requirements and standards. * Lead investigations into complex technical issues or failures related to hardware/software sub-components. * Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions. * Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team. ## Related Videos - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Leveraging Large Language Models for Legacy Code Translation: Challenges and Solutions](https://www.wearedevelopers.com/videos/1157-leveraging-large-language-models-for-legacy-code-translation-challenges-and-solutions) - [JavaScript? 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