Senior Engineer, R&D Sustainment

Senior Engineer, R&D Sustainment (IHFM) - Irvine, CAJoin 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 CADStrong analytical, problem-solving, communication, and teamwork skillsEOE 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  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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