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Job Description
SENIOR MECHANICAL DESIGN ENGINEER
JOB SUMMARY
Responsible for the design, development and verification of complex medical, pharmaceutical and diagnostic devices with a major focus on injection moulded components.
Participates in and acts as technical lead 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 device designs.
- Generate design concepts, proposal, and presentation.
- Leads evaluation of product requirements into product specifications.
- Undertakes prototype manufacture and assembly.
- Leads 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.
- Leads product and manufacturing risk assessment / analysis documentation (PHA, FTA, FMEA).
- Uses data and failure investigations for root causes analysis & leads solutions implementation.
- Applies structured project management approach to all deliverables involving key stakeholders with ability to communicate effectively both internally and externally.
- Leads technical meetings and presentations internally and with external customers.
- Acts as SME on multiple technical areas within the team.
- Works to develop department capabilities in line with strategic goals including mentoring and developing junior colleagues.
- May perform other duties and responsibilities as assigned.
- 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.