Senior Engineer, Medical Device R&D Sustainment

Real; Irvine (CA); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid leave

Job summary

Real is seeking a Senior Engineer for R&D Sustainment in Irvine, CA, focused on lifecycle management of Class III implantable devices. The role emphasizes investigating field/manufacturing issues, driving design improvements, and supporting quality/regulatory activities on-site.

You will collaborate with manufacturing, quality, regulatory, and clinical teams, execute V&V protocols, and contribute to change control and continuous improvement initiatives.

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 and lead root cause analyses when needed.
• Manage risk assessments (FMEA, hazard analysis) for device projects.
• Develop and perform V&V protocols, test methods, and technical reports.
• Analyze product performance data and report findings to cross-functional teams.
• Collaborate with manufacturing, quality, regulatory, and clinical teams; support change control and documentation updates.

Skills

Analytical thinking

Communication

Teamwork

Education

BS in Engineering/Science with 4+ years' experience, MS with 3+ years, or PhD with relevant experience

Tools

Python

Minitab

Excel

CAD

Job description

Real is seeking a Senior Engineer for R&D Sustainment in Irvine, CA, focused on lifecycle management of Class III implantable devices. The role emphasizes investigating field/manufacturing issues, driving design improvements, and supporting quality/regulatory activities on-site.

You will collaborate with manufacturing, quality, regulatory, and clinical teams, execute V&V protocols, and contribute to change control and continuous improvement initiatives.