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Senior Manufacturing Engineer Position Open
3 weeks ago
We are seeking a seasoned Principal Process Development Engineer to join our team. This is a hybrid role that will work in close conjunction with a Galway-based supplier and require the successful candidate to work on-site with the supplier in Galway three days per week.
This role will be responsible for leading process development and manufacturing engineering activities. The ideal candidate will have experience working within ISO 13485/FDA regulated quality systems and a proven track record in manufacturing and process development in a regulated environment.
About the Role- Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts.
- Develop and implement manufacturing capabilities using lean principles and tools, including value stream mapping, poka-yoke, standard work, bottleneck analysis, and line balance.
- Responsible for working with quality, including management of NCMRs and CAPAs, supplier monitoring and audits, risk management, and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations.
- Contribute to the successful execution of departmental and company goals.
- Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
- Bachelor's degree in engineering or a related specialty with a minimum of seven years' experience, with at least three years in a technical leadership role in a biotechnology, pharmaceutical, or medical device industry.
- Experience working within ISO 13485/FDA regulated quality systems, with a strong understanding of risk management methodology.
- A proven track record in manufacturing and process development in a regulated environment, with medical device catheter product experience being an advantage.
- Ability to achieve results in a virtual organization, with experience working with cross-functional teams, project facilitation, and demonstrated ability to complete projects on time.
- Excellent analytical and decision-making skills, with the ability to effectively and efficiently manage consultants, suppliers, vendors, and budgets.
This role offers a unique opportunity to work in a fast-paced, high-growth environment and contribute to the development of innovative medical devices. The ideal candidate will be passionate about engineering concepts and principles, with a strong ability to drive innovative solutions to complex problems.
How to ApplyIf you are a motivated and experienced engineer looking for a new challenge, please submit your application.