Sr. Mechanical Engineer (Must Have Exp with Complex Automation Systems)

Duties And Responsibilities

• Lead or be in sole responsibility for the detail design and sustaining engineering of large complex automated mechanical or electro-mechanical systems and subsystems.
• Develop design input (specifications) for mechanical systems in instrumented products.
• Apply engineering principles, analytical skills, and empirical methods to develop statistically robust designs.
• Design products to meet cost targets. Prepare cost estimates of mechanical components and assembly labor.
• Accurately estimate work effort for specific engineering tasks for schedule allocation of mechanical engineering manpower.
• Lead, contribute to, and participate in technical reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability.
• Assist in test planning and development to ensure instrument systems and sub-systems conform to requirements on reliability and robustness.
• Complete assignments within established schedules and budgets.
• Interact closely with electrical, systems, software, and test engineering functions to develop comprehensive solutions to design problems.
• Generate engineering documents, drawings and specifications to internal and industry standards, including ASME Y14.5M-1994 Dimensioning and Tolerancing.
• Conform to the requirements of ISO 9001 and CGMP standards for the design and development of medical devices.

Knowledge And Skills

• Demonstrated application of engineering principles and techniques, including heat transfer, fluid mechanics, and kinematics and dynamics as applied to machine design.
• Demonstrated knowledge of creating requirements, prototyping, conducting experiments, analyzing data, and writing reports for medical or scientific diagnostic equipment.
• Strong technical judgment and problem solving skills.
• Five years’ experience with solid modeling CAD applications with large assemblies in team environments. SolidWorks and Simulation experience preferred. Applied usage of Geometric Dimensioning and Tolerancing (GD&T) preferred.
• Three years’ experience with complex automation systems.
• Demonstrated ability to perform a root cause analysis, including data interpretation, and corrective action mitigation with complex systems.
• Experience with leading a team, estimating time for engineering tasks, delegating work, and reviewing designs.
• Usage of Design for Six Sigma or similar robust process development methodologies preferred.

Minimum Qualifications

• Bachelor’s Degree in Mechanical Engineering with at least five years relevant experience, or Masters with at least three years of experience
• Must possess product development experience in a regulated industry.
• Medical device and/or pharmaceutical industry experience, with a strong record of delivering products to market or developing commercially viable technology is preferred.