Senior Engineer, Class III Medical Device R&D Sustainment

Real Staffing Group; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Real Staffing Group is seeking a Senior Engineer for the Implantable Heart Failure Management (IHFM) team in Irvine, CA. This on-site role focuses on lifecycle management of Class III implantable devices, investigating field and manufacturing issues and driving design/process improvements.

Responsibilities include root cause analyses, V&V protocol development, risk assessments, data analysis, and collaboration with manufacturing, quality, regulatory, and clinical teams to ensure product safety

Qualifications

• BS in Engineering/Science with 4+ years' experience, MS with 3+ years, or PhD with relevant experience.
• Experience with ISO 13485, ISO 14971, FDA QMS regulations, and medical device regulatory requirements.
• Experience developing/executing V&V protocols, engineering test methods, and technical reports.

Responsibilities

• Execute engineering studies to support sustainment and improvements.
• Manage risk assessments (FMEA, hazard analysis) and CAPA activities.
• Develop and perform V&V protocols, verification and validation testing.
• Analyze product performance data and report findings to cross-functional teams.
• Collaborate with manufacturing, quality, regulatory, and clinical teams.
• Support documentation updates, change control, and ongoing quality monitoring.

Skills

Root cause analysis

FMEA

Hazard analysis

V&V protocols

Engineering test methods

Technical reports

Python

Minitab

Excel

CAD

Communication

Teamwork

Education

BS in Engineering/Science

MS in Engineering

PhD in relevant field

Tools

Python

Minitab

Excel

CAD

Job description

Real Staffing Group is seeking a Senior Engineer for the Implantable Heart Failure Management (IHFM) team in Irvine, CA. This on-site role focuses on lifecycle management of Class III implantable devices, investigating field and manufacturing issues and driving design/process improvements.

Responsibilities include root cause analyses, V&V protocol development, risk assessments, data analysis, and collaboration with manufacturing, quality, regulatory, and clinical teams to ensure product safety