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Project Manager

Job LocationBurnley
EducationNot Mentioned
Salary35,000 - 45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client operates in the Medical Devices business sector and the successful candidate will need to work within this regulatory framework in the Technical Department. The Project Manager will be responsible for successful delivery of Engineering & ProductDevelopment Projects ranging from NPD to manufacturing and engineering of existing portfolio: You will be a Champion for the department and an inspiring leader who engages with staff at all levels to deliver actions against the multidisciplinary projects youmanage, in this internal and external customer-facing role.Main responsibilities include:

  • Create and maintain Project Plans according to company processes and accepted project management tools and techniques.
  • Manage, lead and deliver projects on time and to budget, ensuring the company and customer project procedures are followed, and SoTA and Regulations are considered and adhered to.
  • Ensure the appropriate transfer of products from development to pilot production phase and on to full production phase conducting all agreed realisation activities.
  • Complete Change Control plans and ensure these activities are aligned with project plans.
  • Consider conflicts and mitigation strategies across site projects.
  • Communicate and report on projects as per agreed formats and timescales.
  • Provide technical support and quotations to Sales & Marketing team, where appropriate. Working directly with customers to discuss new projects and resolve design and process issues post-transfer.
  • Identify new technologies and products that could be utilised to facilitate the successful implementation of new products or to support future business needs.
  • Ensure timely escalation of issues to Line Manager and Quality
  • For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.
  • Adherence to QMS, HSE policies and procedures and all other company policies and procedures.
The successful candidate will have ALL of the following attributes:
  • Bachelors degree or equivalent in Engineering, Science, or similar.
  • Experience of a regulated industry (Medical Devices/Pharmaceutical -preferred)
Experience of plastics & metals for use in medical devices & tooling is preferred.
  • Demonstrable experience of leading projects, including facility and bespoke equipment requirements for product manufacture.
  • Experience of tech-transfer and design transfer requirements including product design requirements, process development, validation, change control and other functional requirements.
  • Familiar with product design processes.
  • Good to excellent working knowledge of ISO 13485. Beneficial to have familiarity with other medical device related standards and Regulations i.e. ISO 14971, ISO 11135/37, ISO 9001, MDD, MDR, IVDD, IVDR.
  • Excellent skills in written and spoken English to enable communication with colleagues and to understand technical and QMS related documents.

Keyskills :
Medical DevicesPlasticsProject Management Tools

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