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IVD Project Engineer

Contract Type: Permanent
Location: Unknown
Contact Name: Gavin Kennedy
Contact Email: gavin@rftgroup.ie

Job Description


Project Manager

Our client is an exciting early-stage company based in Dublin whose mission is to revolutionize diagnostic medicine by providing immediate, accurate testing, in the near patient setting. We are looking to recruit an Engineering Manager to resource, plan, and execute engineering activities within assigned areas and the quality of the products produced. The Engineering Manager will be responsible for engineers internally and managing external resources.

JOB PURPOSE
The Project Manager, also known as PM, will be responsible for managing development and manufacturing project progress, coordinating internal and external resources.

DUTIES AND RESPONSIBILITIES
  • Reports to the Chief Operating Officer.
  • Leading project planning sessions
  • Coordinating internal and external resources.
  • Managing project progress and adapt work as required
  • Ensuring projects meet deadlines
  • Overseeing all Design Control Documentation for individual projects.
  • Completing Risk Assessments and designing risk mitigation plan
  • Conducting project review and creating detailed reports for internal stakeholders and clients.
  • Optimising and improving processes and the overall approach where necessary
  • Request quotes from suppliers for project specific materials or services.
  • Generate purchase orders with approved suppliers.
  • Purchase Orders should be forwarded to COO for approval.
  • Participates in preparation of new proposals, reports, and company documentation
  • Participates in preparation of registration submissions for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Conducts and assists with annual appraisal of staff.
  • Implements and leads a continuous quality improvement process, focusing on systems and process improvements.
  • Represents our clients at trade shows and conferences.
  • Co-ordinates and drives the authorship of scientific articles for publication and patent applications. Sources, approves, and manages external collaborators for the development and manufacture of product.
  • Develops and implements Quality System in compliance with, ISO13485, Invitro Diagnostic Regulations (IVDR)and 21CFR820.
  • Acts as a Functional Manager for our client.
  • Acts as member of Executive Management for our clients eQMS.
  • Other duties as defined by our client from time to time.

QUALIFICATIONS
  • Bachelor’s degree with 5+ years of related development and manufacturing hands-on within the medical device industry.
  • Good communication skills for effective liaison and teamwork.
  • Problem-solving skills, analytical skills, and attention to detail.
  • Excellent organisational skills and the ability to work on several tasks or projects concurrently.
  • Commercial acumen and an awareness of the business value of work undertaken.
  • Presentation skills - for presenting ideas and findings to colleagues and customers.
  • The ability to work well independently, with minimum supervision.
  • Drive, enthusiasm, and self-motivation.
  • An aptitude for mathematics and statistics and highly developed it and technical skills.

CV to gavin@rftgroup.ie