Dept. Medical Devices / Pharma combination product Technology.
As an experienced Engineer in the field of medical device or combination product development, you will be responsible for the delivery of Mechanical Engineering R&D best practice within our clients Global R&D organisation.
You will have good state-of-the-art knowledge of the regulations, directives, guidelines and standards relevant to the development of medical devices and combination products. Your breadth of Engineering expertise, knowledge and practices will be applied to creatively solving highly complex problems, and you will also specialise in the design of precision mechanisms and plastic injection moulding processes.
As a specialist in the field of medical device and combination product research and design, you will be identified as a 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 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 our clients 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 Teva’s Quality Management System.
- Graduate in Engineering, Physics or similar discipline.
- Previous experience in working with medical device or combination products R&D.
- Must have proven experience in general Engineering and R&D.
- Training in Design Controls, medical device risk management and European Medical Device Directive/Regulations.
- Experience of design for drug delivery device development, manufacturing and assembly processes.
- Experience of medical device, combination/medicinal product regulatory requirements for global release.
- Experience of Medical Device development and manufacturing processes, preferably for drug delivery applications and/or 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.
- Knowledge of spring design.
- 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.
- Aptitude for working in a team environment and operating outside remit to meet deadlines when necessary.
- Adaptable, cooperative and helpful attitude towards colleagues and customers.
- Ability to influence and educate.
- Analytical approach to understanding and solving problems.
- Enjoys working hard, is driven and able to challenge. Not fearful of acting with a minimum of planning and quickly seizes opportunities.
- Can effectively cope with change, coping with risk and uncertainty while comfortably adapting to changing conditions.
- Enjoys leading and is looked to for direction in a crisis and to remain positive at all times.
ENGINEERING / PHYSICS / R&D / ENGINEER / MECHANICAL / MECHANICAL ENGINEER / RUNCORN / CHESHIRE / STERILE / STERILES / RESEARCH / DEVELOPMENT / GENERIC RESEARCH / MECHANICAL DESIGNS / DEVICE TECHNOLOGY / ANALYSIS / MATHEMATICAL MODELS / INJECTABLE / INJECTABLES / PHARMACEUTICALS / KINEMATIC MODELS / SYSTEM DESIGNS / RISK ANALYSIS / FMEA / CAD / IQ / OQ / PQ / PRODUCT DEVELOPMENT / REGULATORY AFFAIRS / DEVICE NETWORK / RESEARCH AND DEVELOPMENT
- Drug Development
- Global R&D
- Mechanical Engineering
- Product Development
- Pharmaceutical Industry