Senior Manufacturing Engineer

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Job Description

Senior Manufacturing Engineer-JO-2004-448985

Summary :
This is a highly collaborative position working closely with R&D, QA and key suppliers to ensure the effective supply of high-quality finished product for development projects, clinical and commercial activities.The successful applicant will be responsible for manufacturing technical leadership of NPI activities in partnership with R&D and QA functions.

Job requirements:

Principal Responsibilities
 Support the finished device manufacturing subcontractors and suppliers to ensure the Company's product quality, regulatory & business requirements are met.
 Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
 Provide manufacturing engineering support to process and product development projects including responsibility for reporting on project activities.
 Review and contribute to supplier process validation and risk management activities.
 Support resolution of SCAR’s, CAPA's & NC’s ensuring effective solutions are identified, challenged and implemented.
 Assess and approve Supplier and Company process changes ensuring product impact is appropriately considered.
 Compile any necessary equipment / capital authorisation requests supported with appropriate justifications and alternative options.
 Communicate effectively with all Internal & External Stakeholders.
 Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments and lean initiatives.
 Ensure all health, safety and environmental requirements are met.
 The role will involve some European travel to suppliers (up to 20%).

Education & Training Educated to Degree Level (Level 7 or Level 8 FETAC) in a relevant engineering or science discipline.

 A minimum of 5 years’ relevant experience in the medical device industry in a team-based manufacturing or engineering role.
 Demonstrated ability to plan and complete tasks to defined timelines.
 Experience in performing process validation and risk management activities is required.
 Experience of managing internal/external relationships is required.
 Strong decision making and problem-solving skills.
 Excellent verbal and written communication skills.
 Self-motivated, with focus on Quality, Delivery and Cost.
 Experience with lean/six sigma and value improvement project experience is preferred.
 Nitinol stent and catheter delivery system manufacturing experience is an advantage.

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