Project Engineer (EU-MDR) in Belfast at Stryker Corporation

Date Posted: 9/20/2018

Job Snapshot

Job Description

Job Title

Project Engineer (EU-MDR)  

Reports To

Snr. Project Manager (with dotted line report to Project Manager QA/RA)

Position Summary

Responsible for executing within a project management team in supporting EU-MDR and IMO 2.0. roll out.

Key Areas of Responsibility

The Project Engineer will be responsible for following activities:

Liaising with the R&D and ME team to create labelling specifications Liaising with the vendor or internal manufacturing team to design prototype labels Liaising with the Stryker CDCs and regulatory team to obtain approval of labelling requirements Supporting the ME team with label printer sourcing Ensure compliance with Stryker SOPs Support labelling CAPA/NC execution as needed Provide timelines and objectives to the EU-MDR Project Manager

  • Qualifications:

2:1 in Engineering or Science or an equivalent qualification in Project Management

  • Experience:

Minimum of 2 years’ experience in a regulated industry within a project management team

  • Specific Knowledge

An understanding of MDSAP regulations would be advantageous

Knowledge of 21 CFR part 820

Knowledge of ISO 14971 would be advantageous

Previous project management experience would be advantageous

  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position

      Effective Communication Skills

      Highly developed time management skills

      Highly developed technical writing skills

      Highly developed decision-making skills

Work From Home: No

Travel Percentage: None

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