Description:
Provide the design control expertise to the Kilkenny site. You will liaise with global functions to maintain change action plans and impact assessments. Design Transfer Engineer will serve as a technical representative providing design control expertise to product change management teams.
Main Responsibilities
- Support completion of Design Control deliverables for design change projects.
- Develop and write change action plans, design transfer plans, and change impact assessments for changes originating on Kilkenny site, and support drafting of the same for new products being introduced to the Kilkenny site.
- Support the establishment of objectives, measurable, discrete, and reliable customer and product requirements.
- Complete impact assessments of proposed changes and/or introduction of new products and determine scope of validation work.
- Work with relevant functions to define and document validation strategies for new product introductions.
- Maintain a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success.
- Design verification and validation planning and execution, including any cross functional investigation and resolution activities.
- Ensure DHF content completion, integrity and regulatory and standards compliance.
- Collaboration and communicate to identify and resolve any gaps.
- Support risk management activities from product concept through commercialisation.
- Provide support to establish component specification definitions, supplied component sampling plan development and vendor qualifications.
- Support biocompatibility and sterilisation qualification.
- Support audits and quality system improvement activities.
Qualifications & Experience
- Minimum Level 8 NFQ qualification Or Equivalent in a relevant discipline.
- Minimum 3+ years working in a similar role in medical device Design Control process, quality engineering, Research and Development, or Process/Manufacturing Engineering with experience supporting product change and development.
- Project management experience, and the demonstrated ability to work to pre-agreed schedules and report on progress to management advantageous.
- Strong problem-solving and critical-thinking abilities.
- Excellent communication skills, both written and verbal, for technical and non-technical audiences.
- Ability to work independently and collaboratively in a fast-paced environment.