PRINICIPAL MECHANICAL ENGINEER - INDUSTRY SECTOR CHANGE
Job Title Principal Mechanical Engineer (Sector Change);
Reporting to Systems Design and Development Manager;
Department Steriles Device ;
Salary: 50-65k Negotiable;
As an experienced Mechanical Engineer specialising in the design of precision mechanisms and/or complex plastic injection moulded components, you will be responsible for the delivery of Mechanical Engineering R&D best practice within a Global R&D organisation. Your breadth of Engineering expertise, knowledge and practices will be applied to creatively solving highly complex problems.
You will be expected to undertake specialist training relevant to the development of medical devices and combination products. Satisfactory completion of training and probation will result in your role transitioning to Principal Mechanical Engineer.
You will then be identified as a Medical Device Subject Matter Expert both within the Steriles Device Team and other business units. As such you will also contribute to the development and maintenance of departmental operating systems and processes.
- To undertake an initial programme of training with the aim of achieving Medical Device Subject Matter Expert status and transition to a Principal Mechanical Engineer role.
- To perform the role of Design Authority for multiple drug delivery devices at various stages of development, from research, through verification and validation, and into life-cycle. You will be identified within the business as the primary source of detail Engineering knowledge for each device.
- To work with suppliers to ensure that their Engineering output meets your requirements as Design Authority and Expert Engineer. You will routinely perform assessments of their Engineering for quality, robustness and safety, leading suppliers to improve performance where necessary.
- To ensure that every product in your care is robust in design; performing Engineering analysis and routinely providing evidence of robustness, reliability and efficacy.
- To lead or assess safety risk management activities and define the critical components of design.
- To develop mechanical designs to realise technical solutions to meet product, testing and research needs, producing high quality specifications, CAD models and detailed 2D drawings with full GD&T.
- Develop comprehensive product requirements, design history, specifications and verification plans with end-to-end continuity and objectivity.
- Ensure compliance with Quality Management System.
- Graduate in Engineering, Physics or similar discipline.
- Must have proven experience in precision mechanical devices and components, Mechanical Engineering and R&D.
- Experience of product development and manufacturing processes, preferably including electro-mechanical products.
- Competent in the use of statistical methods in the determination of sample sizes, reliability calculations and data analysis.
- Product development experience, from concept to commercialisation.
- Knowledge of Solidworks 3D CAD.
- Mentoring and coaching.
- Experience in designing plastic injection moulded precision mechanisms.
- Analytical engineering assessment of mechanisms and systems.
- Good verbal and written communication including high quality engineering documentation.
- Technical ability, confidence and knowledge to understand and challenge from a "first principles" basis
- Excellent 3D spatial awareness and visualisation of concepts, mechanisms and assemblies, including accomplished use of 3D parametric modelling software.
DRUG DELIVERY / INJECTABLES / STERILES / STERILITY / COMBINATION DEVICES / MEDICAL DEVICES / PHARMA / PHARMACEUTICALS / GMP / ENGINEERING / MANUFACTURING / PROTOTYPE / MANUFACTURING / PRODUCTION / REGUALTORY / CLINICAL / COMPLIANCE / R&D / PRODUCT DEVELOPMENT / DESIGN / ENGINEER / SCIENTIST / CHESHIRE / CHESTER / DERBY / DERBYSHIRE / MANCHESTER / LANCASHIRE / LANCASTER / LIVERPOOL / MECHANICAL / R&D ENGINEER / MECHANICAL ENGINEER / SENIOR / EXECUTIVE / PRINCIPAL / LEADER / PROJECT MANAGER / PROJECT ENGINEER / ENGINEER / ENGINEERING / 13485 / 60601 / FDA / QA / QC / HEALTHCARE / NHS / NUCLEAR / AEROSPACE / AUTOMOTICE / SCIENTIFIC / MEDICAL
- Global R&D
- Mechanical Engineering
- Product Development
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