Description:
This role can be based in Dublin, Ireland or near a major West site in the US. Reporting to the Senior Director of Device Manufacturing, Global Engineering, this role is primarily responsible for establishing and leading the global development and implementation of the Tooling Engineering strategy within Global Engineering whilst ensuring the commissioning, qualification and validation of Tooling and Process related equipment, processes and procedures are carried out in accordance to GMP and relevant guidelines. This role will have direct and functional responsibility for Tooling Engineering within the newly established Global Device Manufacturing Engineering function and will be responsible for supporting the execution of various engineering projects relating to medical device manufacturing within West. This role will lead the harmonization of tooling principles, practices and procedures across Device Engineering. This role will direct the application of resources within and across its functional responsibility to assist global sites in improving the manufacturing of products and develop the most optimum processes and solutions which meet or exceed West and/or customer requirements.
Essential Duties And Responsibilities
- Provide technical leadership and direction to a globally dispersed Tooling Engineering team with responsibility for defining strategy, planning and execution of Tooling and Process activities within the global Device Manufacturing network.
- Provide strategic leadership of long-term and intermediate goals within Device Manufacturing and Technology in collaboration with the Global Engineering/Operations Network.
- Supports the development and execution of the strategic plan to achieve short- and long-term business objectives.
- Supports operations in establishing the technology and equipment requirements needed to deliver against the customer needs and facility operational goals and objectives.
- Direct resources from functional responsibility for Tooling Engineering in support of Device programs within CM and Proprietary Device manufacturing.
- Lead the harmonization and implementation of Tooling Engineering standards and procedures across the Device Manufacturing Network based on current regulations, industry standards and industry practices.
- Drive innovative and efficient approaches to asset validation incorporating science and risk-based approach.
- Review and approve cGMP documents including, but not limited to, validation master plans, protocols, and reports.
- Provide Tooling expertise for assessment of changes, deviations, CAPAs and audit findings.
- Support CM Sales team in all new business quoting and gathering customer requirements relating to Tooling Engineering requirements.
- Serve as primary technical contact on strategic or politically sensitive issues.
- Lead, mentor, and develop a project team or direct reports.
- Understands CM manufacturing facilities’ needs, goals, and objectives and identifies technology solutions to support them.
- Identify, execute, and implement transactional process improvement initiatives with regards to the commercialization of products.
- Build strong cross functional working relationships with stakeholders to ensure high quality deliverables meeting cGMP and West procedural requirements.
- Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company.
- Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
- Lead and manage a high performing team to deliver the defined business goals & objectives.
- Other duties as assigned.
Basic Qualifications
- Bachelor’s degree in a technical discipline to include Engineering/Quality/Science.
- Minimum of 10 years’ experience in a regulated manufacturing environment.
- Must have in-depth / working knowledge of: ISO 13485; EU GMP, CFR Part 820.
- Relevant experience in a cGMP regulated industry.
- An excellent understanding of prototype and production tooling, plastic process manufacturing, analytical methods and testing and documentation systems is desired.
- Previous people management experience with demonstrated ability to lead, influence and train others.