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Job Description
Senior Mechanical Design Engineer sought to lead design, development, and verification of complex medical devices with a focus on injection moulded components.
Responsible for developing devices from requirements to product introduction, applying mechanical, manufacturing, and medical engineering knowledge. Participates in cross-organisational efforts to design, develop, and implement robust designs with verification, design for manufacturability, and regulatory compliance.
Key Responsibilities
- Deliver design, development, and verification of complex assemblies, sub-assemblies, components, and packaging.
- Generate product design and CAD models of complex device designs.
- Develop design concepts, proposals, and presentations.
- Lead evaluation of product requirements into product specifications.
- Undertake prototype manufacture and assembly.
- Lead evaluation of product specifications through engineering study and proof of concept testing.
- Select and review materials.
- Develop and implement changes to existing products to achieve performance, quality, and cost improvements.
- Lead product and manufacturing risk assessment and analysis documentation.
- Analyse data and failure investigations to identify root causes and implement solutions.
- Apply structured project management approach to deliverables involving key stakeholders.
- Lead technical meetings and presentations internally and with external customers.
- Act as subject matter expert on multiple technical areas within the team.
- Mentor and develop junior colleagues to develop department capabilities in line with strategic goals.
Requirements
- Master's degree in Mechanical or Biomedical Engineering or related field.
- Minimum of 5 years of related experience and/or training.
- Competency in CAD Modelling (preferably Solidworks/Creo).
- Understanding of Tolerance Analysis, 2D Drawings, GD & T.
- FEA analysis desirable.
- Knowledge of engineering theories, design principles, and practices.
- Knowledge and understanding of regulatory requirements including ISO13485.
- Demonstrated leadership ability with clear ownership of deliverables and responsibilities.
- Strong communication skills with proven ability to lead cross-functional teams.
- Excellent problem-solving skills.
- Ability to work in a team environment.
- Strong analytical capabilities.
- Excellent attention to detail and Quality focus.
- Proven documentation writing skills.