Job Title: Design Engineer I
Responsible for the design, development, and verification of complex medical and diagnostic devices with a major focus on injection moulded components.
Key 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.
* M 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.
Requirements:
* Bachelor's degree in Mechanical or Biomedical Engineering or related field.
* Master's or Min 1 year relevant experience preferred.
* Competency in CAD Modelling (Preferably Solidworks / Creo).
* Understanding/Competence in 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.