Design Engineer

Job Description

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 / Creo)
• 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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