Senior Medical Device Systems Engineer – V&V Expert

Diality Inc.; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Diality Inc. is seeking an experienced engineering professional to lead design control efforts for the Moda‑flx Hemodialysis system. You will drive DHF deliverables, decompose requirements, and manage risk per ISO 14971 across hardware and software components.

You will coordinate verification and validation activities, perform root cause analysis, and guide cross‑functional teams toward compliant, high‑quality medical device solutions.

Qualifications

• BS/BA in a relevant engineering field with 5+ years of related experience or 3 years with a Master’s degree.
• Solid systems engineering across the product lifecycle with requirements, change control and traceability.
• Experience with design verification/validation and regulatory requirements for medical devices.

Responsibilities

• Lead cross‑functional team through the design control process.
• Prepare DHF deliverables including PRS, System Architecture, System Hazard Analysis, and FMEA.
• Decompose User Needs into product and subsystem requirements.
• Lead risk management per ISO 14971.
• Plan and coordinate verification and validation testing with internal and external partners.
• Develop and validate test methods to verify product requirements.
• Perform system level verification testing to ensure compliance.
• Lead investigations into complex technical issues or failures.
• Apply RCA and FMEA to implement robust corrective actions.
• Share knowledge and lessons learned to foster engineering excellence.

Skills

Regulatory compliance

Engineering tools

Scripting languages

Problem solving

Communication

Project delivery

Education

Bachelor's in biomedical, electrical, mechanical, systems or software engineering

Tools

SolidWorks

Minitab

Job description

Diality Inc. is seeking an experienced engineering professional to lead design control efforts for the Moda‑flx Hemodialysis system. You will drive DHF deliverables, decompose requirements, and manage risk per ISO 14971 across hardware and software components.

You will coordinate verification and validation activities, perform root cause analysis, and guide cross‑functional teams toward compliant, high‑quality medical device solutions.