Job Description
My client a leading Medtech company now require a Senior Manufacturing Project Engineer to join their expanding team.
The Senior Manufacturing Project Engineer will be responsible for the technical management of external contract manufacturing partner(s). They will deliver engineering solutions to the business regarding external contract manufacturers. They will lead and/or support engineering projects including process validation, continuous improvement, manufacturing transfer etc.
This is a permanent role based in The Midlands commutable from parts of Dublin and Galway.
Responsibilities of Senior Manufacturing Project Engineer
Partner with Manufacturing and Quality to achieve required business operational control and agreed service levels regarding Contract Manufacturers (CM).
Deliver technical and engineering solutions to the business regarding the process at CM.
Collaborate with manufacturing departments to support product availability from CM against build commitment & schedule.
Plan, facilitate and execute engineering projects with CM to drive effective cost structures and control.
Provide engineering oversight of change control on technical matters, such as process validation and manufacturing transfer......etc., within CM.
Lead, coordinate and execute manufacturing transfer of projects on the new product development or/and design change of sustaining products.
Actively manage the portfolio of engineering projects within CM.
Review and approve supplier change requests and companyitiated change requests.
Actively manage technical issues within CM using structured methodologies. Activities may include conducting device evaluations related to product / process issues and performance.
Provide technical oversight, support and guidance to CM on process development, process validation, test method validation (TMV), risk assessment and design for manufacture (DFM).
Partner with BIFG in initiating & driving product cost reduction and continuous improvement strategies with suppliers.
Facilitate and drive continuous improvement with CM in terms of product quality and service.
Exercise project management discipline on technical projects as appropriate in achieving business objectives
Requirements of Senior Manufacturing Project Engineer:
Minimum 5-year experience in a manufacturing or production engineering environment.
Minimum of 3-year experience in medical devices
Demonstrated understanding of cGMP, Design Control and Validation practices.
Strong leadership, decision-making & problem solving skills.
Process Excellence qualification or training or knowledge of principles; competency in Six Sigma, practicing Green Belt a plus.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below