Ophthalmology Med-Device R&D Engineer II - Full Lifecycle

Real Staffing; Tustin (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Real Staffing partners with a leading ophthalmology medical device company to recruit a hands-on Product Development Engineer. You will work across the full lifecycle—from concept through design transfer, DV/VC, and manufacturing transfer—impacting patient outcomes.

The role requires a Bachelor's in Engineering and 4+ years in medical device product development, including Class II/III devices, with strong Design Controls, DV/V&V, and regulatory knowledge. Based in California, on-site.

Qualifications

• Bachelor's Degree in Engineering or related technical discipline.
• 4+ years of Product Development experience within the Medical Device industry.
• Experience developing Class II and/or Class III medical devices.
• Strong understanding of Design Controls and regulated product development.
• Experience with Design Verification (DV), Validation, and V&V activities.
• Knowledge of DOE (Design of Experiments), TMV, and equipment qualification protocols (IQ/OQ/PQ).
• Experience using SolidWorks.
• Strong analytical and problem-solving skills.

Responsibilities

• Support product development activities from concept through design transfer and commercialization.
• Develop product specifications, manufacturing methods, and technical documentation.
• Lead and support DV, Validation, and V&V activities.
• Execute IQ/OQ/PQ and test method validations.
• Perform hands-on laboratory testing, experimentation, troubleshooting, and data analysis.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Operations teams.
• Support regulatory submissions and product improvements across existing product lines.

Skills

Analytical thinking

Problem-solving

Cross-functional teamwork

Regulatory knowledge

Education

Bachelor's Degree in Engineering or related technical discipline

Tools

SolidWorks

DOE

TMV

IQ/OQ/PQ

Job description

Real Staffing partners with a leading ophthalmology medical device company to recruit a hands-on Product Development Engineer. You will work across the full lifecycle—from concept through design transfer, DV/VC, and manufacturing transfer—impacting patient outcomes.

The role requires a Bachelor's in Engineering and 4+ years in medical device product development, including Class II/III devices, with strong Design Controls, DV/V&V, and regulatory knowledge. Based in California, on-site.