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Development Engineer

Zenopa
Job LocationGateshead
EducationNot Mentioned
Salary£40,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

My client are successfully established as one of the world leaders in the IVD industry. They are well known as a global market manufacturer of electrophoresis systems and reagent tests designed for the clinical and analytical market segments. Their systems are designed to automate large scale testing of patient samples for rare cancers, chronic disease states and blood diseases.We are searching for a Development Engineer that can help design, develop and test innovative technology solutions and systems before the production phase. The Development Engineer will be part of an Applications R&D team inside Helena Biosciences’ group of companies to help design and develop the next generation in IVD automation. My client is looking for people who have a passion for innovation and who enjoy solving intricate engineering problems. The role will be to take ownership of hardware designs from assisting with requirements specifications, generating hardware specifications, schematic entry though to PCB layout, fabrication, commissioning, verification and managing systems integration into platforms.Your responsibilities will include:

  • Lead and support research, development and design projects, coordinate with internal external suppliers and stakeholders, manage project progress against targets.
  • Develop products and designs, taking method of manufacturing into account, produce manufacturing drawings and documentation.
  • Ensure technical specifications for materials or production processes are clearly identified and communicated.
  • Create and present technical documents and reports for both internal and external use.
  • Research and investigate technologies and processes to ensure that the Company remains aware of latest developments.
  • Expert in designing systems that implement complex biochemical assays and able to navigate the technical and cost trade-offs to develop well balanced’ products.
  • Career in diagnostic device development preferable but not obligatory; ideally having been involved in product launch.
  • Project leadership skills to empower the team and drive development efficiently and effectively towards well-defined goals. Track record of leading device development projects, taking responsibility for quality, time, and profit.
  • Support product design, software integration, validation and handover to production with other Engineering team members.
  • Ensure the products are designed for EMC, Environmental and other regulatory approvals.
  • Highly creative and highly technical in many of the following areas: concept generation; engineering and statistical analysis and detail design; design of experiments; design for high and low volume manufacturing.
  • Familiar with working to ISO 13485, 21CFR820 and ISO14971; design control; compilation of Design History File; verification and validation.
  • Ensure effective communication and coordination suppliers, stakeholders and project managers.
  • Identify and source Regulations and Standards to support product development.
  • Any additional work identified as necessary for the smooth operation of the business.
  • A good understanding of the complete product development process preferably for automated equipment working high-reliability environments.
  • Knowledge of the product approvals process to meet CE, EN and the relevant product approvals (emissions, susceptibility, environmental)
  • You will have experience of designing products and solving engineering challenges. You will also have an understanding of general manufacturing techniques and engineering materials including moulded plastics, metals, and sensors. With Good 3D CAD skills needed for the preparation of manufacturing drawings and document control during the production process.
  • You will also be able use your analytical and strategic thinking skills whilst handling time pressures to meet production and delivery deadlines. It is also preferable that you have a degree level education in a related engineering field; although this is not essential.
    • Organisational Responsibilities:
  • Contribute to the company’s long-term goals by delivering right first-time hardware designs.
  • Ability to deliver on-time and build good working relationships with cross-functional team members and external departments, acting as a technical lead when required.
  • Take responsibility for own projects and delivery to tight timescales, communicating through plans, presentations and written reports.
  • Provide time and effort required for hardware activities for input into the project planning process.
  • Contribute to hardware design reviews when appropriate to ensure quality designs.
  • Strongly self-motivated and able to take ownership of problems and finding solutions.
  • Excellent communication skills and team working. Self-starter. Flexible can-do attitude.
    • Requirements:
  • HNC/D or Degree in Mechanical Engineering
  • 3D CAD - SolidWorks (or similar)
  • Proven track record in Medical Devices sector (or similar e.g. Scientific)
  • Experience working on R&D based projects
  • ISO 13485 (desirable)
    • Required skills
  • CAD
  • Mechanical Engineering
  • Product Design
  • Product Development
  • R&D Operations

    • Keyskills :
    CAD Mechanical Engineering Product Design Product Development RD Operations

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