Senior Mechanical Design Engineer

2 days ago

Baltimore, Maryland, United States MILLENNIUMSOFT Full time
Job Summary

We are seeking a highly skilled Senior Mechanical Engineer to join our team at MillenniumSoft. As a key member of our engineering team, you will be responsible for designing and developing complex mechanical systems for medical diagnostic instrumentation.

Key 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.
Requirements
  • 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.
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.

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