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. Applies mechanical, manufacturing, and medical engineering knowledge to develop devices from requirements and specification to product introduction. 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. EDUCATION & EXPERIENCE 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.
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