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.
Key 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 and 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.