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Instrument Development Engineer-Medical Devices

Short Profile

  • Established Immunodiagnostic Company selling into international market
  • Small company with great work culture
  • Design/Innovation is the key here!

Exciting opportunity for a brilliant Instrumentation Engineer with experience in Medical Device design and associated regulatory standards

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Job Category: Engineering

Job Type: Full-Time

Area: Auckland-Central

Published: January 11, 2019

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Introduction

Our client have developed novel and patented technology for cost effective and user friendly immunodiagnostic testing of a range of diseases. With an advanced multiplexed test platform giving rapid result turnaround, the company is in advanced commercialisation stage of existing platforms, whilst concomitantly expanding into other disease diagnostic panels, based on their proprietary technology.

The technology includes an image processing software which is the key to interpret the diagnostic assays. As the Instrument Development Engineer, you will collaborate with all the team to ensure instrument/software solutions developed meet the commercial, regulatory and functional performance needs. You will provide technical project management for the entire product life cycle and ensure the device/solutions are compliant to ISO 13485 standards.

Requirements

Your key responsibilities will include:

  • Lead and support Instrument Development team.
  • Interpret the assay needs and develop associated design inputs for the instrument.
  • Perform or review validation activities and risk assessments in compliance with Design and Development requirements.
  • Provide technical expertise to quality related matters.
  • Assist with the customer services and complaint process where required.
  • Writing technical reports and documentation.

 

Essential Skills, Knowledge and Personal Attributes sought are:

  • Bachelors (or higher) of Engineering in Electrical/Electronics/ Mechatronics Engineering/Industrial Design or a relevant qualification.
  • Strong experience in development of complex, sophisticated, software and controlled medical devices / IVD instruments.
  • Knowledge of regulatory requirements for medical devices.
  • Technical writing skills where you are adept at creating and reviewing SOPs and other associated documentation. Experience in quality system processes, ISO 13485 and validation of new equipment is highly desirable.
  • Highly developed analytical and problem solving skills.
  • Excellent communication skills both verbal and written.
  • A highly motivated, results driven attitude.

This is an exceptional opportunity where you will be awarded a competitive salary along with an opportunity to work with highly accomplished scientific team and consolidate your career in medical device sector.

If this professionally rewarding opportunity excites you, apply online today with a CV and Cover letter in WORD format only, quoting job number 04/1901/PB.

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