The Mechanical Engineer is responsible for mechanical design, testing, and documentation responsibilities in the development of new instrumentation for the biodefense, clinical and life-science markets. Design work will include the design of precision mechanisms and complex assemblies that include machined, molded and sheet-metal components. The incumbent is responsible for the documentation, prototyping and testing of designs and will work closely with other team members from a variety of engineering and scientific disciplines to provide advanced instrumentation solutions to MSD’s customers.
DUTIES AND RESPONSIBILITIES:
EXPERIENCE AND QUALIFICATIONS:
- Closely work with cross-functional teams in the development of new instrumentation
- Design, prototype, test, and troubleshoot new instrumentation designs
- Contribute to the development of requirements and specifications for new instrumentation
- Develop and implement test protocols for both informal and formal design testing
- Design, build, and test manufacturing test fixtures to support manufacturing of new instrumentation
- Develop written assembly and test procedures for new instrumentation designs
- Interact with outside vendors to source parts
- Perform design and development work in conformance with ISO and FDA cGMP processes
- Specific duties may vary depending upon department requirements
- Master’s degree in Mechanical Engineering
o Bachelor’s degree with progressive engineering experience/responsibilities
- Minimum 5 years of experience in the design and development of precision electro-mechanical systems, especially in a cGMP, ISO, or other regulated environment
o Experience in testing of electro-mechanical systems
- Experience in the design of injection molded components
- Medical or scientific instrument design experience preferred
- Demonstrated CAD experience is required
o Experience with Solidworks, I-DEAS, Pro/Engineer or AutoCad is a preferred
KNOWLEDGE, SKILLS AND ABILITIES:
- Demonstrated understanding of GD&T tolerancing practices preferred
- Solid understanding of manufacturing technologies including machining, molding and sheet metal processes
- Demonstrate ability to develop, integrate and validate systems, in a GMP, ISO or other regulated production environment for pharmaceuticals, biotech or medical devices manufacturing is a plus
- Working knowledge of the manufacture of FDA regulated devises is a plus
- Strong engineering fundamentals and analytical background
o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
- Excellent oral, written, and interpersonal communication skills
o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data
- Proficiency in MS Office suite
- A wide degree of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities.
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
This position is performed in R&D, light-manufacturing, and engineering office environments.