Job Details

ID #17122044
State Indiana
City Warsaw
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source Denken Solutions
Showed 2021-07-22
Date 2021-07-22
Deadline 2021-09-20
Category Et cetera
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Labelling Engineer

Indiana, Warsaw, 46580 Warsaw USA

Vacancy expired!

Currently, we are looking for talented resources for one of our listed clients. If interested please reply to me with your updated resume or feel free to reach out to me for more details at

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Title: Labelling Engineer

Location: Warsaw IN

Duration: Long Term

Experience: 5-8 Years

Job Description:

The labeling engineer will be a labeling coordinator and subject matter expert (SME) to work with the cross-functional team and Customer. This role will interface with the project team and gather labeling requirements and update labels to comply with new regulations and/or support business needs.

The labeling engineer will facilitate the labeling activities to establish labeling content/ requirement, changes, update for product labels. This role will engage with and mobilize the cross-functional team to resolve regulatory gaps effectively, be responsible for coordination between customer SMEs and offshore teams and collaborate on continuous improvement initiatives.

The candidate needs to work with the offshore team for the label gaps, remediation, labeling software for the draft labels, final labels, label routing, PLM change process management. He/She needs to solve the queries from the offshore labeling team. Needs to present the status at the onsite, attend meetings, update status.

Required Skillset:
  • Customer Management
  • Co-ordination with global teams
  • Medical Devices experience
  • EU-MDR Experience
  • Client facing skills, Good communication skills, Knowledge of Medical devices, knowledge of Medical device labels, label gap assessment, labeling software, knowledge of Medical Device labeling standard ISO 15223-1:2012

Preferred Skillset:
  • Previous experience with Prisym Label Management or Robar or Illustrator or InDesign or Label Vision or Bartender Software
  • 2+ years of experience in a labeling creation environment
  • Highly capable of attention to detail and accuracy
  • Experience using Agile PLM Import Tool and competent in Agile searches
  • Experience working in a regulated environment
  • Knowledge of European Union Medical Device Regulations
  • Experience in cross-functional, cross-geography coordination
  • Experience working with cross-geography programs and teams
  • A good understanding of an end-to-end labeling process
  • Knowledge of process excellence, process improvement
  • Exceptional verbal and written communication, negotiation, and partnering skills
  • Demonstrated ability to drive a collaborative, customer-focused, learning culture
  • Experience using Agile or a Product Lifecycle Management system preferred
  • Excellent people and communication skills (verbal and written)

Must to have:
  • EU MDR Gap Ana and Remediation for labeling
  • Understanding and Experience in Labelling Tools
  • The 15223-1:2012 standard for medical device marking and labeling.

Adds Value:
  • RAC Certification: Medical Devices

Good To Have:
  • US and EU Submission
  • Worldwide regulatory agencies/authorities
  • Support EU MDR Transition activities

Education:
  • Bachelors / Masters in Bio Medical Engineering or Mechanical Engineering
  • Must Have: Minimum Requirements
  • To be considered for this role, please ensure the minimum requirements are evident on your resume.
  • Bachelor's degree with 2 - 5 years' related experience or Master's degree with 2 - 3 years' related experience in Biomedical / Mechanical
  • Must have experience in Medical Device Industry

Vacancy expired!

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