Vendor Process Engineer

Location

Galway - Ireland

Department Name

Manufacturing

Functional area

Engineering

Reports To

Operations Manager

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 vendor’s 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 inhouse representative of the vendor inhouse 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

  • 4 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 travel may be required with role.

Closing Date for Application

17th April 2017

Aerogen is the world’s leading medical device company specialising in the design, manufacture and commercialisation of aerosol drug delivery systems. 

Founded in Galway, Ireland in 1997, we have grown to become the global leader in high performance aerosol drug delivery, partnering our technology with the leading mechanical ventilation companies. 

Aerogen technology is used by millions of patients and caregivers in over 75 countries worldwide.

To find out more go to www.aerogen.com 

Some of the benefits our employees enjoy at Aerogen: 

  • VHI including Dental
  • Pension
  • Bonus
  • DIS
  • PHI
  • On-site Free Parking
  • Paid Holidays
  • Sports & Social Club
  • Flexi- Start Time.