Overview

The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the production/manufacturing/Lifecycle Management functions.

 Responsibilities

  • Provide technical support on all product and processing related issues.
  • Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved.
  • Product Transfers and Manufacturing process set up and scale up.
  • Apply “Lean” principles to production lines considering 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.
  • Provide ongoing day to day support to Production; continually seeking to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot production related issues, implementing “robust permanent fix” solutions.
  • Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Work Instructions, Manufacturing procedures and Logs.
  • Set up and order Product, Components, Consumables, and Material necessary for validation and production.       
  • Manage Tooling and Equipment spare parts inventory to support manufacturing capacity.
  • Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
  • Partner with all stakeholders across the business to ensure that the transition of products through product lifecycle are smooth, timely and cost effective.

Qualifications

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

 Competencies and Attributes

  • Proven technical expertise and competence across all aspects of manufacturing engineering function including lean.
  • Demonstrated expertise and detailed knowledge of the medical device industry.
  • Equipment Procurement and Validation experience.
  • Has 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.
  • Good 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 regarding 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 team environment.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Ability to stay connected to multiple projects simultaneously.
  • Proactively enacts change where required and implements new processes and routines to give effect to that change

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