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.
Contribute 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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