Senior Engineer

#MON

Summary:

• Work as a key member of the project team in the design, development and analysis of medical devices or surgical instrumentation products, materials, processes, or equipment.
• Work cooperatively on a cross functional development team under the guidance of the project manager -  compile, analyze, and report operational, test data and other pertinent information to establish and verify performance standards for newly designed and/or modified products, processes, or materials

Responsibilities:

• Create innovative concepts, designs and approaches for new products, processes and test methods
• Translate customer needs into product development requirements and specifications
• Coordinate the design, procurement, and fabrication of tooling and fixturing
• Generate tolerance analysis studies, component drawings and inspection methods
• Develop, direct, and analyze engineering verification tests and mechanical analyses
• Successfully complete design control product development tasks including: writing and/or verifying specifications; creating and maintaining product and process documentation; creating design failure modes and effects analyses; testing processes, equipment, raw materials and products; and validating equipment and test methods
• Prepare and analyze engineering reports to document and communicate results of product testing and verification/validation activities
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Requirements:

• BS in an Mechanical Engineering/Biomedical Engineering or a Technical Field
• Minimum of 5 years of experience in the product development of medical devices
• Working knowledge of medical device ISO, cGMP, and QSR standards
• Understanding of machining, injection molding and extrusion methods (experience with plastic assembly and joining processes a plus)
• Proficient with SolidWorks