Senior Medical Device Systems Engineer — V&V & Compliance

Diality, Inc.; Irvine, Northern (CA, KY); Ibrido; USD 140.000 - 180.000; Tempo pieno

Descrizione del lavoro

Diality, Inc. in Irvine, CA is seeking an experienced Systems Engineer to lead design control and risk management for the Moda-flx Hemodialysis system. This role focuses on DHF documentation and regulatory compliance across the product lifecycle.

You will coordinate V&V activities, guide cross-functional teams, and ensure product requirements are translated into verifiable designs and tests, in a collaborative medical device environment.

Competenze

• Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering.
• 5+ years of related experience or 3 years with a Master’s in engineering.
• Solid systems engineering across the product lifecycle.
• Strong experience in risk management (FMEA, fault tree).
• Experience in design verification and validation per regulatory requirements.

Mansioni

• Lead cross-functional team through the design control process.
• Complete DHF documentation deliverables including Product Requirement Specification, System Architecture Document, System Hazard Analysis, FMEA.
• Collaborates with stakeholders to decompose User Needs into requirements.
• Lead the risk management process in ISO 14971 compliance.
• Develop verification and validation test plans and coordinate testing activities with internal and external teams.

Conoscenze

Medical device regulations

FDA QSR

ISO 13485

ISO 60601

ISO 14971

SolidWorks

Minitab

Python

MATLAB

Problem solving

Communication

Project delivery

Formazione

Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering

Strumenti

SolidWorks

Minitab

Descrizione del lavoro

Diality, Inc. in Irvine, CA is seeking an experienced Systems Engineer to lead design control and risk management for the Moda-flx Hemodialysis system. This role focuses on DHF documentation and regulatory compliance across the product lifecycle.

You will coordinate V&V activities, guide cross-functional teams, and ensure product requirements are translated into verifiable designs and tests, in a collaborative medical device environment.