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Date Added: Wed 08/06/2022

Senior Manufacturing Engineer

Swillington, UK
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Company: CORNERSTONE TECHNICAL SOLUTIONS

Job Type: Permanent, FullTime

Salary: £45000 - £55000/annum

A client of ours, a large multi-national medical device company are looking to recruit a Senior Manufacturing Engineering to join their site in Swillington, Leeds on a permanent basis. The successful candidate will be responsible for the leading manufacturing and process development engineering activities, process improvement and equipment management to support manufacturing.

Ideally candidates will be degree qualified in a Mechanical or Biomedical Engineering discipline, with demonstrable experience of equipment qualification and design verification. Process validation in a regulated industry is required.

Experience with medical device manufacturing, clean room production and an understanding of validation processes is highly advantageous.

Open to candidates from a more junior background looking to progress their career within a rapidly expanding medical device manufacturing company

Hours - Monday to Friday - 7AM - 2.30PM (Flexible working available)

This role offers a great package including 28 days leave + Bank Holidays, Pension, Healthcare and company performance related bonuses.

Job Responsibilities:

Analysis of manufacturing KPI's and the development of continuous improvement projects to drive throughput and yield improvements.

Partner with Manufacturing, Quality and R&D Engineers across multiple sites to develop and validate critical processes.

Undertake root cause analysis to identify opportunities to optimise/improve manufacturing processes including using continuous improvement engineering methods (e.g., SIX Sigma and LEAN methods).

Develop tooling, assembly jigs and fixtures, employing technical design skills in support of operational activities, including test method validation (TMV) and cost/yield considerations.

Equipment Management including validation (IQ, OQ, PQ) and managing preventative maintenance and calibration requirements.

Develop training and Quality Documentation (e.g., work instructions) for production processes.

Provide technical support for Quality documentation within the QMS such as DCO's, design qualifications, design transfer, activities for regulatory submissions, equipment management, product, and process development.

Support the analysis and resolution of manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations).

Technical engineering support for the design transfer and production of THV clinical devices, as well as commercialisation activities, by ensuring R&D processes are characterised and scaled up by utilising new technology and standard work.

Lead manufacturing support tasks; give guidance to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work where appropriate.

Train, coach, and mentor lower-level employees.

Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools.

Development and execution of experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and issue reports.

Support internal Quality Audits.

Maintain records and adhere to all aspects of QMS in the completion of their duties.

To comply with and support the company HS & E policies and procedures.

Qualifications / Experience:

Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.

Minimum of 5 years' experience in a medical device manufacturing environment (or other similar regulated industry) is required.

Knowledge of equipment qualification and design verification, process validation in the medical device industry or other regulated industries is required.

Understanding of statistical techniques is required and must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.

Six sigma green belt (or higher) and/or lean mfg. certification.

Must be able to work effectively and collaborate within cross-functional teams.

Must take initiative, communicate status and objectives and be able to conduct hands-on work.

Effective communication and project management skills are required.

Strong knowledge of ISO 13485 requirements.

Must be able to handle multiple tasks with high attention to detail.

Note: This vacancy is being advertised by Cornerstone Technical Solutions Ltd who are acting as an Employment Agency
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