Senior Process Development Engineer
I am working with a leading Medical Device company who, due to a large capital investment have a requirement for a Senior Process Development Engineer.
The Senior Process Engineer will be responsible for design, research, development and project management of new processes.
- Full responsibility for the process development life cycle from creation through to commercial validation.
- Conduct material selection (performance and biocompatibility requirements).
- Design and develop methods for verification and validation testing of product requirements in accordance with regulatory compliance.
- Participate in supplier selection for manufacture, tooling and components.
- Prepare technical documentation in clear and concise terms in accordance with good engineering practice.
- Be prepared to represent such documentation in an audit by customers, revenue or regulatory authority.
- Liaise closely with and communicate effectively to the R&D, manufacturing, operations, quality, sales and marketing functions through the product development lifecycle.
- Perform other assigned tasks as directed by supervisor or head of function
- 6-10 years’ experience in a medical process development or manufacturing environment
- Degree in an engineering or technological discipline
- Excellent understanding of ISO 13485 and FDA design and development processes.
- Technical leadership and/or project management experience
If you would like to find out more about this or any other roles, please apply now for immediate consideration.
The candidate must have the rights to work in the location stated in the job advert.
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Republic of Ireland
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