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Process / NPI Engineer Medical Technology

TEC PARTNERS LIMITED
Job LocationCambridge
EducationNot Mentioned
Salary£45,000 - £50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Process/NPI Engineer - Biotech - CambridgeThis role is an exciting opportunity for an experienced Process/NPI Engineer to join one of the fastest growing Biotechs in Cambridgeshire, who are developing next-generation instruments for characterising proteins.You will lead the translation of engineering & software requirements into scalable and effective production solutions, from design through to implementation, delivering instruments and consumables both on-time and to the desired quality. You will work collaboratively with other teams to develop and improve processes for new and existing products.Duties and responsibilities will include:

  • Develop a deep understanding of our products, from parts specifications, to assembly and performance testing, allowing you to work with the Engineering, Production, Software and Quality departments to design, implement and improve all the required documentation, tools, jigs and rigs to build instruments and consumables on time and on quality
  • BoM review and solid MRP understanding
  • Define, review, and implement Production URS, DFMA and FMEAs for new products
  • Translate complex engineering concepts into standardised, easy to understand instructions
  • Write and maintain all relevant production SOPs to build and test existing and new instruments and consumables
  • Using Lean & CI tools, lead investigations from identification to resolution, creating and updating troubleshooting guides
  • Implement and maintain SPC controls and monitoring tools (control charts, CPk etc.)
  • Continuously improve and optimize production KPIs, such as quality, efficiency and cost metrics
  • Lead all process related training in production
    • Requirements:
  • Degree educated in an engineering discipline, with at least 5 years of relevant experience in production support/sustaining and/or process development, design, scale-up, improvement and validation
  • Proven experience as a Process Engineer, NPI Engineer or similar, in the medical device, electronic, or complex electromechanical industry
  • Solid experience implementing Statistical Process Controls (SPC) in Production and driving continuous improvement efficiencies. Lean & 6Sigma green or black belt certifications desirable
  • Demonstrable project management skills with a high level problem solving and reasoning skill
  • Well-developed documentation and technical reporting skills
  • Demonstrated use and understanding of Product Data Management Systems, Change Control processes and New Product Introduction required, ideally in a regulated ISO 13485/ GMP environment
  • Comfortable working in areas of high ambiguity ad complexity in a fast paced environment
  • Strong interpersonal communication skills with the ability to positively influence others and build relationships
  • Ability to collect, prepare and present relevant information to influence decision making within the organisation
    • This role offers an excellent opportunity join a market-changing biotech who are going from strength to strength. You will be working on challenging engineering projects, and will develop as the business does. If this sounds like your next challenge, then get in touch right away with an up-to-date CV.

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