Research And Development Engineer -Urology (Irvine)

Mechanical Engineer Acquisition & Integration Project

Contract Duration : 6 months (with potential extension)

Pay Rate : Up to $69 / hour

Work Model : Hybrid (3 days onsite)

Preferred Locations : Irvine, CA (primary) | Arden Hills, MN (secondary)

About the Role

A leading Urology Research & Development organization is seeking a highly skilled and motivated Mechanical Engineer to support an acquisition and integration initiative. This role focuses on aligning the acquired companys Design History File (DHF) with internal compliance standards. Youll assess design verification, test methods, and outputs to determine testing needs and either execute tests or update documentation to justify test waivers.

Youll collaborate with subject matter experts while applying your expertise in mechanical and systems design, test method validation, verification testing, and statistical analysis.

Key Responsibilities

• Identify gaps in DHF compliance and contribute to strategies for resolution
• Provide input on project goals, progress, and recommend revisions
• Communicate risks, trade-offs, and technical deliverables to project leadership
• Develop and apply new techniques for efficient integration of medical device technologies
• Execute engineering tasks such as :
• Design FMEA
• Design Verification test methods
• Test method validation
• DV protocols, testing, and reports
• Essential Design Output identification
• Requirements tracing
• Evaluate feasibility of alternative engineering processes and equipment
• Produce clear, concise documentation (protocols, reports, rationales)
• Demonstrate strong knowledge of Technology and Product Development systems

Required Qualifications

Preferred Qualifications