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Job Description
Senior Mechanical Design Engineer responsible for designing, developing, and verifying complex medical, pharmaceutical, and diagnostic devices with a focus on injection moulded components.
As a key member of the team, you will be responsible for delivering design, development, and verification of complex assemblies, sub-assemblies, components, and packaging. You will work closely with cross-functional teams to design, develop, and implement robust designs with appropriate verification, design for manufacturability, and regulatory compliance.
Key Responsibilities:
- Deliver design, development, and verification of complex assemblies, sub-assemblies, components, and packaging as assigned.
- Generate product design and CAD generation 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.
- Materials selection and review.
- Develop and implement changes to existing products to achieve performance, quality, and cost improvements.
- Lead product and manufacturing risk assessment/analysis documentation.
- Use data and failure investigations for root cause analysis and lead solutions implementation.
- Apply structured project management approach to all deliverables involving key stakeholders with ability to communicate effectively both internally and externally.
- Lead technical meetings and presentations internally and with external customers.
- Act as SME on multiple technical areas within the team.
- Work to develop department capabilities in line with strategic goals including mentoring and developing junior colleagues.
Requirements:
- Master's degree or equivalent 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/Competence in 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; clear and concise using objective evidence and language.