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Vendor Engineer - Ireland  

Company managed [?] Still accepting applications

Posted on : 10 July 2017

Project Description

Job Summary
Responsible for managing and supporting vendors on engineering and quality projects for components and sub-assemblies for Class II products in a high variety electro-mechanical Medical Device manufacture, assembly, test and packaging environment.


Duties / Responsibilities
  • Ensuring that vendors possess the necessary skills, expertise and certification.
  • Ensuring that all externally sourced parts conform to specification.
  • Identifying with the vendors areas for improvement to include: increased capacity, better quality, improved reliability, more efficient manufacture and better customer service.
  • Scoping out and project managing such improvement projects.
  • Monitoring and statistically analyzing process data, quality and production yields.
  • Monitoring and ensuring that key process indicator (KPI) targets are delivered and met.
  • Be the main in-house representative of the vendor in-house and the champion for all associated improvement initiatives.
  • Implementation of lean and operational excellence principles (6σ, 5S, TPM)
  • Identifying new and additional vendors.
  • Participating in vendor approval and surveillance audits to ensure fit for purpose.
  • Leading process and components approvals at vendor sites.
  • Liaise with stakeholders (colleagues & suppliers) to derive the necessary outcomes.
  • Be prepared to represent such documentation in an audit by customers, revenue or regulatory authority.
  • Maintain compliance with all manufacturing and quality related documentation
  • Perform other assigned tasks as directed by Supervisor or  Head of Function


Specific Requirements
  • Meticulous attention to detail with a methodical and analytical approach with good problem solving tool skillsets
  • Very strong organizational and Project Management Skills
  • Knowledge of Design Verification and Process Validations, particularly as it pertains to equipment and manufacturing processes.
  • Green or black belt certification an advantage.
  • Knowledge of electro-mechanical components and sub-assemblies and related processes an advantage
  • Excellent understanding of ISO 13485 and FDA Design and Development Processes.
  • Excellent planning and communication skills.
  • Ability to work effectively as part of a multi-disciplinary team is a key requirement.
  • Experienced in dealing with marketing, and regulatory teams.
  • Ability to lead complex problem solving and cost/capacity improvement projects with cross functional teams.
  • Ability to present ideas and concepts clearly and effectively.
  • Familiar and comfortable with standard medical device documentation.
  • Ability to grasp and statistically analyze data to achieve desired outcomes.
  • Highly motivated self-starter with an innovative mindset.

Education / Experience
  • 5 years’ equivalent experience in a Medical Process Development or Manufacturing Environment
  • Minimum of a primary degree in an Engineering or Technological Discipline
 

Environmental Conditions 
  • Typical office environment with work also performed in Development labs and Manufacturing areas in addition to customer/supplier locations
  • Some national and international travel will be required with role (up to 30%



Some of the benefits our employees enjoy:
  • VHI including Dental
  • Pension
  • Bonus
  • DIS
  • PHI
  • On-site Free Parking
  • Paid Holidays
  • Sports & Social Club
  • Flexi- Start Time.