Job Description

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 companys Design History File to client's compliance
• Responsible for assessing the acquired companys 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 companys 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:

• BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
• 4+ yrs of engineering or related experience with bachelors degree, or 2+ yrs with Masters
• Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• 10% travel is possible.

Education/Experience:

• Medical Device experience
• Familiarity with IEC 14708 and 45502 Active Implantable standards
• Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
• Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
• Experience in single-use device or active implantable test methods and test method validation.

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