Design Control Engineer – Medical Devices
Scientific & Technical Recruitment Limited
Auckland City, NZ
3d ago
source : Jobnos
  • Innovative Biotechnology / Medical Device company
  • Exciting products, fast paced dynamic environment
  • Expanding company offering excellent career prospects
  • Fantastic opportunity for a Design Control Engineer with a strong Medical Device background in Product Design or Design Quality to join a leading organisation.

    Introduction

    Award winning and privately held, this South Auckland Medical Devices manufacturing company is undergoing further expansion.

    They have developed cutting edge tissue regeneration technology, with the main emphasis of the company being improvement of patient welfare, simplifying operating procedures and reducing healthcare costs.

    Due to growth and expansion, an exciting opportunity has arisen for a bright, energetic and self-motivated Design Control Engineer to provide support to new product development and market launch by writing and managing the Documentation for Design Development and Production process.

    Your responsibilities will focus around Design controls as well as risk management across a number of projects.

    Key to your success in this role will be your ability to fully document the product design, development and modification process and ensure the products are compliant with international medical device standards.

    You will be a practical person with out of box’ thinking where you are diligent in your risk assessment process.

    Requirements

    Your key responsibilities will include :

    Complete control of the documentation process for design, development and modification to existing and new product development processes to ensure products achieve quality and compliance standards.

  • Implementing Medical Device Design Controls as per the latest regulatory directives.
  • Ensure that Design History files for processes and design implementations are maintained consistent with GMP, ISO 13485, FDA, EU and other relevant directives.
  • Lead and / or support risk analysis activities. Create and manage risk management files as per company procedures to ensure risk management documentation is kept up-to-date.
  • Support development and design activities to ensure data is generated and maintained in compliance with documented procedures.
  • Ensure the analysis and presentation of information to management concerning measures of product, process and service quality, manufacturing problems, training and audit activities and design issues as identified through various design control program elements.
  • The ideal candidate will bring :

  • Relevant tertiary level qualification in Engineering or Science
  • 5 years’ experience in the Medical Device industry in Product Design or Product Quality.
  • Good knowledge and working application of FDA CFR 820, ISO, TGA regulations and relevant EU directives
  • Strong understanding of design controls; the ability to develop and execute design plans, design verification and validation.
  • Great analytical and problem-solving skills
  • Outstanding interpersonal, verbal and written communication skills
  • Attention to detail
  • Experience with both Microsoft Word and Excel.
  • Strong organizational and project management skills
  • Ability to work with autonomy
  • This role will be both rewarding and provide ongoing challenge, where you will be a critical bridge between the R&D and Operations team.

    We seek applications from lateral thinkers who will make value added suggestions to continued process improvement.

    If you are confident in your skills and this opportunity sounds exciting to you, please apply today with an updated CV (in WORD Format only) and Cover Letter to gareth str.

    co.nz quoting reference 03 / 1909 / GR or call at (09) 525 5520 for more information.

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