Mechanical Engineer

We are looking for a Mechanical Engineer to join our Engineering Team who are responsible for providing mechanical, product and process engineering expertise in the development of consumer diagnostic products working within the wider R&D function. SPD (Swiss Precision Diagnostics) are world leaders in the research, design, and supply of advanced consumer diagnostic products. SPD is a joint venture business between P&G and Abbott and our brand Clearblue is recognised the world over as providing accurate home pregnancy and fertility monitoring tests. SPD has been certified as a Great Place To Work in both the UK and Switzerland. In this role you will provide mechanical, product and process engineering expertise to the department and R&D projects, including prototyping on-site using workshop machinery and hands-on manufacturing on the development and post-market support of consumer in-vitro diagnostic products in a GMP compliant environment. You will be involved in...

• supporting activities on assigned projects throughout the development process ensuring core considerations for user focussed design, mechanical engineering analysis, design for manufacture and design for assembly.
• generating and understanding end user requirements and translation of these into ideas and concepts.
• using and promoting 6 Sigma/Design for 6 Sigma tools to ensure Design for Manufacture and Assembly (DFMA) is adopted during design concept generation and selection.
• identifying key technical and manufacturing challenges and providing resolutions.
• creating, developing, and reviewing requirement documentation (specifications, mechanical analysis reports, BOMs, drawings, design transfer documentation, etc.)
• risk analysis, ensuring careful consideration of risks related to tasks, costs, and timelines, including developing contingency plans, and regularly reviewing and updating risk assessments and process FMEA sessions in accordance with regulatory requirements (FDA 21 CFR 820, IVDR, ISO 13485)
• interpreting data, identifying trends, and making predictions about future performance.
• planning and performing testing of development solutions, analysing results, drawing conclusions, writing reports with recommendations, and presenting these to the business, including the evaluation of materials, prototypes and components.
• hands on prototyping including manufacturing and arranging for jigs and fixtures.
  
  A relevant Mechanical Engineering degree
• Technical experience in an industrial environment with experience of mechanical engineering, manufacturing, design transfer and process engineering
• Experience of developing products throughout the product development lifecycle in accordance with their relevant regulatory standards, preferably within the medical device arena- IVDR, ISO 13485, FDA 21 CFR Part 820.
• Experience of production scale up, robustness and validation activities in accordance with relevant regulatory standards
• Experience of process improvement tools and techniques, process validation, process scale up and design transfer and project management.
• Experience of analysis techniques such as Tolerance Analysis and FEA.
• Experience in Design for Manufacture and Assembly, root cause analysis and of process optimisation using Design of Experiments and other Six Sigma tools.
• The ability to work in a fast-paced environment, with a flexible working approach to accommodate the changing priorities of the business.
• Excellent communication skills, including report writing and verbal presentations of findings.
• The willingness to travel in the UK and abroad.
  
  Competitive salary and bonus
• 25 days paid annual leave plus bank holidays
• Company pension scheme with competitive employer contribution
• Private Medical Insurance with additional Medical Cash Plan
• Enhanced maternity and paternity pay
• Company supported employee Health & Wellbeing programme
• Life assurance
• Free electrical car charging points
• Free parking
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes Northampton, and London
Closing date Applications should be received by 6th January 2025. Right to Work All candidates will be asked to provide proof of eligibility to work in the UK at interview. Due to the requirements laid out by UK Visas and Immigration regarding Right to Work in the UK, SPD can only accept applications from individuals who currently have a status allowing them to work in the UK for this position. We regret that we are unable to offer sponsorship currently. Equality SPD is committed to providing a vibrant, ethical, and sustainable work environment that values equality, diversity, and inclusion. If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help. If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help. SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products. Our SPD research centre is at the cutting edge of innovation, and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.