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- Full Time
- Mid-Senior Level
CREGG Recruitment are currently hiring a Engineering Manager for a small medical company in Galway. This is a 12 month contract role with a view to longer term depending on FDA approvals.
About the role
The Engineering Manager will work as a key member of the management team and product development teams.
You will be integral in the development of innovative manufacturing processes and strategies for our client medical devices technologies in accordance with the requirements.
Overall responsibility for Engineering and Projects including
- Equipment & processes available to support manufacturing
- Technical support to operations and suppliers to ensure reliable product
- Project management & delivery
Duties and Responsibilities
- Manage the design transfer of products into operations ensuring that sound engineering principles are employed to meet the required timelines and design intent.
- Manage and facilitate process development including process support, troubleshooting and optimisation.
- Ensure that manufacturability and product cost impact (materials and processing) are considered in all decision making when implementing process and design changes.
- Ensure appropriate and required engineering, equipment and project documentation is generated and is maintained in line with the QMS and associated regulatory requirements.
- Manage and support projects to ensure projects are prioritised and delivered to meet the company’s objectives.
- Lead the team through the required product development “stage gate” process for design and process changes.
- Manage the process validation program in compliance with current regulations, with the objective of outputting a robust process with appropriate controls capable of supporting CE
- Mark and international compliance.
- Manage and support vendor technical/design changes to ensure changes are implemented using a risk-based approach and in line with the QMS and associated regulatory requirements.
- Manage first article process to ensure new and updated components meet the form, fit and function requirements.
- Ensure Bill of Material updates are generated and implemented in line with the QMS and associated regulatory requirements.
- Support the development and maintenance of comprehensive PFMEAs to provide input data for validation activities.
- Manage operations test methods and ensure test method validation requirements are included in the scope of validation activity.
- Support operations facilities management and maintenance plans. (including cleanrooms)
- Minimum 10 years operations/engineering experience in an engineering role in the medical device industry with a successful history of manufacturing line setup, product, and process validations.
- Strong knowledge of the EU and US regulations for the manufacture and supply of medical devices.
- Experience in selecting and assessing vendors for medical device component production and assembly.
- Strong background and experience in the set-up, validation and optimisation of manufacturing processes and associated test methods.
- Hands on and team leader experience in product development and stage gate processes.
- Strong knowledge and experience utilising statistical techniques.
- Experience with design control based product development.
- Strong knowledge and experience of medical device assembly and packaging requirements.
- Excellent communication and organisational skills.
- Excellent analytical skills with experience in application of problem-solving.
techniques, to troubleshoot and resolve complex technical issues.
- Experience in project managing development projects.
- Ability to work autonomously and take ownership of activities.
- Ability to work with a diverse range of technologies.
- Very good technical report writing skills.
- Knowledge of clean-room manufacturing processes and methodologies.
- Ability to work well in a team environment and provide mentoring for the engineering and operations resources.
For more information on this role, please call Breda Murphy at CREGG Recruitment 0860262157