Senior Mechanical Engineer

Job Title : Sr. Mechanical Engineer (Medical Device)

Duration : 6+ Months (Possible extension)

Location : Irvine, CA 92618

Hybrid Role

Responsibilities :

• The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated Mechanical Engineer.
• Provide support in integrating the acquired company’s Design History File to client's compliance
• Responsible for assessing the acquired company’s design verification, test methods, and design outputs to determine if additional testing is required and either running the appropriate tests or updating associated documentation to rationalize why no testing is required.
• As a key team member, you will provide testing solutions and technical support under some guidance from our subject matter experts.
• Utilize your background in mechanical and / or systems design, test method design and validation, verification testing and statistical analysis.
• Identifying gaps in the acquired company’s DHF compliance to Work Instructions and SOPs and contributing to strategy to close these gaps.
• Successfully completing engineering work in one or more of the following : Design FMEA; Design Verification test method; test method validation; DV protocol, testing, and report; Essential Design Output identification; and requirements tracing,
• Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
• Completing clear and concise engineering documentation, including protocols, reports, and rationales.
• Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.

Education / Experience :

Education / Experience :