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Manufacturing Engineer - Medical Device

Manufacturing Engineer - Medical Device

Job Title: Manufacturing Engineer - Medical Device
Contract Type: Temporary
Location: County Galway
Industry:
Salary: DOE, negotiable
Duration: 1 year contract (initially)
REF: CE10365
Contact Name: Aoife McDonnell

Job Description

Overview

The Manufacturing Engineer is responsible for performing a variety of technical and support roles to the production / manufacturing department.

Responsibilities

  • Set up a new Manufacturing Process.
  • Manage the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved.
  • Design, procure and construct “Lean” production lines taking into account flow optimisation, throughput time, product movement, layout and space.
  • Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment.
  • Set up Preventive Maintenance and Calibration routines.
  • Lead the knowledge transfer of this new manufacturing process and provide training to product builders and technicians.
  • Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot issues implementing “robust permanent fix” solutions.
  • Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
  • Set up and order Product, Components, Consumables, and Material necessary for validation and production.     
  • Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
  • Generate and gain approval for project budgets and subsequently manage expense and capital expenditure in line with this budget.
  • Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective

Qualifications

  • Engineering Degree or equivalent.
  • A minimum of 3 years’ experience in a similar role
  • Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design and Lean Manufacturing highly desirable.

Competencies and Attributes

  • Demonstrated expertise and detailed knowledge of the medical device industry and in particular combination medical devices. Familiarity with Drug and other Coating techniques.
  • Experienced in Product Transfers and Manufacturing process set-up and scale-up.
  • Equipment Procurement and Validation experience.
  • Proven technical expertise and competence across all aspects of Manufacturing Engineering function including lean.
  • Has prepared SOPs, conducted IQ/OQ/PQs and/or validations previously in a regulated environment.
  • Effective knowledge of the regulatory environment in which the business operates.
  • Proven written and oral communication skills and an ability to prepare competent business cases.
  • An analytical approach to problem solving.
  • Oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
  • Is creative, continually learning and exploring new ideas.
  • High level of flexibility required with regard to role and prioritisation of activities
  • A self-starter applies his/her own initiative in most situations.
  • A good team player who works well in a small team environment.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Ability to stay connected to multiple projects simultaneously.

Role:

1 year contract (initially)