This role will develop and maintain Engineering-owned systems and participate in administration activities associated with the Product Lifecycle Management system.
Standardise local procedures for Engineering activities to reflect global procedures and policies ensuring an efficient and compliant process, whilst simultaneously ensuring compliance with the latest revisions of medical device regulations, FDA CFR 820, ISO 13485, ISO 14971 and other relevant industry standards. This role includes the review of the relevant standards and the integration of their interpretation into the Quality Management System, as well as executing the necessary activities to ensure product compliance.
Responsibilities:
- Develop and maintain Engineering-owned quality systems and procedures for product and process development and improvement.
- Liaise with local functions to enhance/develop processes and systems.
- Ensure Engineering quality systems comply with latest revisions of medical device regulations, FDA CFR 820, ISO 13485, ISO 14971 and other relevant industry standards. This incorporates the review of the relevant standards and the integration of their interpretation into our QMS.
- Execute activities required to ensure product compliance with identified standards.
- Support Engineering personnel in the review and implementation of appropriate standards to support device and system needs.
- Encourage consistent use of product and process controls across Engineering group.
- Develop and maintain Project log and system for Engineering.
- Agile PLM system:
- Develop an understanding of the system design / setup.
- Develop an understanding of how migration to the Agile PLM platform influences other computerised systems
- Aid in software validation of the Agile PLM software, as necessary.
- Develop into a systems administrator role and provide support to internal personnel on the use of Agile PLM software.
- Develop/maintain quality system procedures for the management / utilisation of the Agile PLM system.
- Update existing quality system procedures / create new procedures to interface
existing processes into the Agile PLM platform.
- Participate in notified body audits.
- Ensure high engineering standards are established, implemented and maintained across all Engineering groups.
- Regular communication to local management.
- Support cross -functional teams to achieve company goals.
Qualifications / Requirements:
- Third level degree in Mechanical, Biomedical, Design, Chemical Engineering/Science, or similar discipline.
- 3 years product or process development/improvement experience.
- Good Project Management methodology and skills.
- Proven track record in delivering quality results in a timely effective manner.
- Innovative/creative Engineer.
- Strong communication and inter-personal skills.
- Good presentation skills (working knowledge of MS PowerPoint).
- Strong technical writer.
- Team-player with ability to develop strong working relationships.
- Good problem-solving skills.
- Strong organisation and management of computerised data skills
- Highly motivated individual, self-starter with a passion for excellence.
- Willingness and availability to travel on company business.
This role can be Hybrid .
