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Date Added: Sat 10/07/2021

Npi Engineer

Bristol, UK
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Job Type: Permanent, FullTime

Salary: £34200 - £42800/annum holidays, pension, health cover

A wonderful opportunity for an excellent NPI Engineer to relocate to a thriving area with an outstanding quality of life in the West of Ireland!

Our Client requires a proven candidate with a background in commercial transfer of innovative product-designs within a GMP/FDA/ISO regulated medical devices industry. Candidates must have a minimum of 3 years of experience in the transfer of products and packaging-systems from design-freeze through qualification to commercial manufacturing. Due to exciting growth on a number of new product/ technology introduction, the successful candidate will liaise heavily with cross-functional NPI (new product introduction) teams which can encompass R&D, manufacturing-engineering, maintenance, EH&S, quality-engineering and supply-chain functions. He/She will work as part of a team to develop and maintain high quality/performance/safety standards on all assigned implant-products. Reporting to the NPI Manager, the position will be challenging, involve exposure to the latest Tier1-company implant product-designs and will require an ability to work autonomously.

Duties and Responsibilities

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Contribute to the New Product Introduction (NPI) teams with key input into

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Scaling, development, and validation of product, and packaging.

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Equipment procurement and facility layout.

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Initial capacity planning and identifying production operator needs.

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Development of production and Quality procedures.

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Material sourcing and procurement including supplier qualificationinput

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design-for-manufacturing and product flow/layout development.

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Take ownership for the execution of process qualification related builds an testing.

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Ownership of IQ, OQ, PQ protocol-generation, execution and reporting.

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Initiate, maintain, update and review manufacturing, quality and engineering-related documentation as required - driving and reviewing Engineering Change Notice (ECN) proposals.

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Assist with training of product builder staff on key operational tasks.

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Enjoy a multi-departmental approach to problem-solving where everyone has a voice and is respected for their input in driving root-cause-analysis reviews.

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Always strive to meet or exceed the expectations of our customers.

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Perform facility-based EH&S, layout or energy-savings projects as required.

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Coordinate and manage teams in meeting internal and external (customer) quality, timeline and budget commitment in transferring product and packaging designs into fully qualified commercial manufacturing processes.

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Deploy the principles of lean and six-sigma in identifying and implementing the optimum areas for improvement in manufacturing operations.

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There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organisation.

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Make appropriate decisions on a daily basis, using the NPI Manager and Senior Engineering (NPI, Operations, Quality) representatives as needed.

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Performs other related duties, as assigned.

Key Requirements for the role

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Reporting to the NPI Manager the successful candidate must have a track record of success in a manufacturing environment for a medical device company, a degree in Engineering or related field and 3 years' experience in a medical device engineering role.

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Candidate must be highly motivated and passionate about developing new products with strong documentation, oral, and interpersonal communication skills required.

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The individual must be proficient in Medical Device design principles and material selection with a knowledge of FMEA, TMV, MVP, IQ/OQ/PQ and software validation.

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Possess strong analytical skills, with a hands-on approach.

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Project management experience is desirable
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