Mechanical Engineer

Technical expertise:

• Design: compact, miniature, light-weight opto-mechanical architectures.
• Design: high-precision opto-mechanical assemblies in short to mid-IR wavelengths (3 um to 5 um).
• Design: de-sensitize optical designs to environmental influences (e.g. thermal, vibration, atmospheric).
• EDA Tools: SolidWorks, Zemax, FEA.
• Reliability: de-rating analysis, Six Sigma (DFSS), failure analysis, physics-of-failure.
• Regulations: IEC 60601-1, IEC 60601-1-2, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR, etc.
• Solid Opto-Mechanical Engineering fundamentals and problem solving skills up through system-level.

Education and Experience:

• Bachelor’s or Master’s Degree in Mechanical Engineering.
• 5 - 10 yrs of experience in medical device (capital equipment) or related fields (regulated industry preferred).
• Technical lead on opto-mechanical engineering programs.
• Strong working knowledge of hardware (electrical, optical, mechanical) and software / firmware.
• Experience in designing to comply with EMC and ESD requirements.
• High reliability designs, DFT, DFM, (medical devices preferred).
• Compact, miniature, high-density designs, (medical devices preferred).
• Knowledge of ASME Y14.5 Dimensioning and Tolerancing.
• Design verification test development, execution, report generation.
• In-depth knowledge of product development process and design control from concept to volume production.
• In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.
• In-depth knowledge of medical device regulations and standards (e.g. IEC 60601-1, EU-MDR, FDA cGMP).
• Understanding of capnography or gas sensing products, applications, and technologies a plus.
• Six Sigma (DFSS) Green Belt certification with actual project experience a plus.
• Solid OEM / ODM / CM experience.

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