MECHANICAL DESIGN ENGINEER JOB SUMMARY Responsible for the design, development and verification of complex medical and diagnostic devices with a major focus on injection moulded components. Applies mechanical, manufacturing, and medical engineering knowledge to develop devices from requirements and specification to product introduction. Participates in cross-organisational efforts to design, develop and implement robust designs with appropriate verification, design for manufacturability and regulatory compliance for seamless product introduction.
ESSENTIAL DUTIES AND RESPONSIBILITIES Delivers design, development and verification of complex assemblies, sub-assemblies, components, and packaging as assigned.Product design and CAD generation of complex medical device designs using SolidWorks. Generate design concepts, proposal, and presentation.Participates in definition of product requirements into product specifications.Undertakes prototype manufacture and assembly.Participates in evaluation of product specifications through engineering study and proof of concept testing.Materials selection and review.Develops and implements changes to existing product to achieve performance, quality, and cost improvements.Contributes to product and manufacturing risk assessment/analysis documentation (PHA, FTA, dFMEA, uFMEA).Analyses data and conducts failure investigations to determine causes of problems and develop & implement solutions.Applies structured approach to all deliverables involving key stakeholders with ability to communicate effectively both internally and externally.Contributes to technical meetings and presentations both internally and with external customers.Research new technology or development tools to remain informed of current innovations.May perform other duties and responsibilities as assigned. EDUCATION & EXPERIENCE REQUIREMENTS Bachelor's degree in Mechanical or Biomedical Engineering or related field.Minimum of 1-3 years of related experience and/or training.Competency in CAD Modelling (Preferably Solidworks).Understanding/Competence in Tolerance Analysis, 2D Drawings, GD & T, FEA analysis desirable.Knowledge of engineering theories, design principles and practices, and design evaluation techniques.Knowledge and understanding of regulatory requirements for medical devices including ISO13485.Excellent problem-solving skills.Ability to work in a team environment.Strong analytical capabilities.Excellent attention to detail.Ability to work on own.Strong attention to detail and Quality focus.Proven documentation writing skills; clear and concise using objective evidence and language.
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