Senior Engineer, 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

Senior Engineer, R&D Sustainment (IHFM) - Irvine, CA

Join the Implantable Heart Failure Management (IHFM) team to support the lifecycle management and continuous improvement of Class III implantable medical devices. This on-site role focuses on investigating field and manufacturing issues, driving design and process improvements, leading root cause analyses, and supporting engineering change control activities to ensure product safety, quality, reliability, and regulatory compliance.

Key responsibilities include executing engineering studies, managing risk assessments (FMEA, hazard analysis), developing and performing verification and validation (V&V) protocols, analyzing product performance data, and collaborating with manufacturing, quality, regulatory, and clinical teams. The role also supports documentation updates, change control, and ongoing quality monitoring.

Required 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

Preferred Qualifications

• Experience with Class III implantable medical devices
• Knowledge of design controls, CAPA, complaint investigations, risk management, and change control
• Proficiency with Python, Minitab, Excel, and CAD
• Strong analytical, problem-solving, communication, and teamwork skills

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.