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Manufacturing Engineer Medical Devices

Otodynamics Ltd
Job LocationHatfield
EducationNot Mentioned
Salary£31,000 - £36,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Otodynamics Ltd, based in Hatfield Hertfordshire has designed and manufactured electronic medical hearing testing instruments for sale to hospitals/private clinical and military facilities around the world for over 30 years.As the Manufacture Engineer, you will assist the Operations Manager to ensure that all manufacture activities are well run and help lead day to day production activities remaining actively involved in assembly, calibration and configuration of a range of products as well as carrying out quality inspections on both components and assemblies. You will be responsible for driving continuous process improvement within the business to enhance quality, generate operational efficiencies, reduce product lead times, and deliver financial savings. You will become an expert in the manufacture of our product range and support the Research and development team with investigation and new products being released in to manufacture.This role is an excellent opportunity and will ideally suit an experienced Engineer, who enjoys delivering lean, continuous improvement or process improvement projects. While also remaining hands on in an electronic production environment and enthusiastic with assisting Research and Development with new product transition in to manufacture.Your Role & Responsibility

  • Responsible for the in-house product build assembly and quality of our new and existing product range, completing to them to specification, in line with set key performance indicators (KPIs).
  • Follow detailed assembly instructions and processes/procedures to correctly assemble medical devices.
  • Accurately maintain medical device history records and statistical data, ensuring assembly of high-quality medical devices is properly documented.
  • Hands on building and testing electrical/electronic assemblies. Soldering and rework of both surface mount and through-hole technology passive and active devices, e.g. for rework purposes, using no-clean techniques etc..
  • Accurately and methodically troubleshoot during the build of products.
  • Investigate complex technical issues, present root cause with adequate solutions which will be implemented in a timely manner.
  • Compile and report any inconsistencies that prevent successful builds or performance of a product to the R&D Division and as required by our WIRs and our Quality Management System (QMS).
  • Identify and analyse potential opportunities for process improvement, demonstrating the expected business benefits.
  • Update and create assembly documentation in conjunction with the Research & Development team.
  • Development of appropriate measure to evaluate the impact of process improvements, post-implementation .
  • Manage the implementation of process improvements with overall responsibility for project deliverables, time-lines and stakeholder management.
  • Ensure that all process adaptations are managed in accordance with the Quality Management System and, with strict adherence to all Health and Safety requirements.
  • Support the Research & Development Division in testing and production of products.
  • Oversee a clean and well organised work area to facilitate good manufacturing functions and practices.
    • Your Skills & Experience
  • Minimum 5 year+ electronics experience working in a assembly or production environment is essential. With hands-on experience of assembly and soldering of SMD components including fine pitch devices and preferably trained to IPC-A-610 and J-STD-001 preferred.
  • Ability to read and understand component and assembly drawings/schematics.
  • Good dexterity / hand-eye coordination with exceptional soldering skills under Microscope.
  • Experience working within a quality managed system and regulatory requirements (ISO, FDA, MDSAP).
  • Ability to quickly read and understand schematics and assembly drawings.
  • Familiar with using digital multi-meter, power supplies, oscilloscopes and other common electronics lab equipment, and able to demonstrate accuracy handling data.
  • Previous experience of working to KPIs, and the ability to work under pressure is essential to this role.
  • Highly computer literate with experience in Microsoft Office: Outlook, Excel and Word.
  • Proven analytical and practical approach to solving problems with capability to be resourceful and proactive in dealing with issues that may arise.
  • Strong verbal and written communication skills.
  • Excellent team worker.
  • Experience working within a quality managed system and Knowledge of continuous improvement principles.
  • Good time management.
    • Desirable
  • Very strong background in microscope soldering of small wires, such as micro coax cable 38AWG (will be assessed as part of the recruitment process).
  • Previous medical device assembly experience preferred (or experience in another regulated environment)
  • Experience using MRP/ERP software.
  • Production supervisory experience.
  • Previous experience liaising with suppliers and research and development teams.
    • Your Qualification
  • Minimum qualification: Level 4 (HNC) or higher in Electronic Engineering discipline - or comparable work experience.
    • Required skills
  • Assembly
  • Medical Devices
  • Process Improvement
  • Soldering
  • Electronic Engineering

    • Keyskills :
    Assembly Medical Devices Process Improvement Soldering Electronic Engineering

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