Manufacturing NPI Engineer – Biotech – Cambridge
This role is an exciting opportunity for an experienced Manufacturing 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.
Manufacturing NPI Engineer responsibilities:
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
Manufacturing NPI Engineer 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.
Salary: £45000 – £50000/annum
Job Type: Permanent
Location: Cambridge, Cambridgeshire
To apply for this job please visit www.cv-library.co.uk.