Senior Engineer, R&D Sustainment
Listed on 2026-10-26
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Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer
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
- 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.
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