Diality

Sr. Systems Engineer

Irvine, CA, US

18 days ago
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Summary

Company & Job Overview

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.


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.


Responsibilities

  • 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.


Required Skills & Abilities

  • 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.
  • Has experience in system architecture design and control system design.


Education & Experience

  • 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.


Physical Requirements

  • Standing for periods of time
  • Lifting equipment up to 40 lbs.


Travel

  • Up to 5%

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