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.
Support the finished device manufacturing subcontractors and suppliers to ensure that our clients 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, CAPAs & NC’s ensuring effective solutions are identified, challenged and implemented.
Assess and approve Supplier and our clients 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.