R&D Engineer II

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

Are you a hands‑on Product Development Engineer looking to work on innovative medical device technologies with a direct impact on patient outcomes? We are partnering with a leading ophthalmology‑focused medical device company that is expanding its R&D team and investing heavily in several exciting New Product Development (NPD) and New Product Introduction (NPI) programs.

This is an opportunity to get in on the ground floor of multiple next‑generation projects while also supporting and improving an established portfolio of commercial products. You'll have the chance to work across the entire product lifecycle—from concept development and prototyping through design verification, validation, manufacturing transfer, and commercialization.

Why This Opportunity Stands Out:

• Several new NPD and NPI programs on the horizon, offering strong project visibility and career growth
• Hands‑on engineering role with exposure to the full product development lifecycle
• Opportunity to support both current products and next‑generation technologies
• Collaborative and highly experienced team making a meaningful impact in the ophthalmology space
• Ability to influence product design, testing, validation, and manufacturing activities

Key Responsibilities:

• Support product development activities from concept through design transfer and commercialization
• Develop product specifications, manufacturing methods, and technical documentation
• Lead and support Design Verification (DV), Validation, and V&V activities
• Execute equipment qualifications (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

Required 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), Test Method Validation (TMV), and equipment qualification protocols (IQ/OQ/PQ)
• Experience using SolidWorks
• Strong analytical and problem‑solving 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, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, 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.