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Senior Risk Engineer – Risk Management for Medical Devices

Description

Do you want to ensure safe and reliable medical devices, helping patients to better treatment?

Are you ready to apply your Risk Management skills to medical devices in a cross-functional projects, delivering on time and quality to customer satisfaction?

Do you want to cooperate with highly skilled colleagues to bring new products to market in a fast-growing and successful global company?

Then you may be the person with the Risk Management skills we are looking for in our office in Denmark (Virum or Struer).

What You Will Do In Your Role

  • Responsible for planning, leading and executing Risk Management activities in R&D projects
  • Work closely with teams across sites under design control
  • Ensure that we adhere to QMS and our Risk lifecycle process
  • Ensure communication to various stakeholders

The Experience You Will Bring

Requirements:

  • Proven experience with ISO 14971
  • Knowledge and understanding of medical device development and design control
  • Experience working with R&D cross functional teams
  • Proven experience and skills in writing and maintaining documentation
  • Strong teamwork capabilities and ability to take lead on workstreams
  • Great communication skills to effectively communicate across sites
  • Self-driven and able to plan and execute own work

What Will Put You Ahead

  • Knowledge and understanding of IEC 62304
  • Experience as embedded SW developer
  • Strong technical understanding

Phillips-Medisize A/S is an expert in the design, development, and delivery of advanced drug delivery devices and connected health solutions. The customers are leading pharmaceutical companies worldwide. Phillips-Medisize A/S is a part of Phillips-Medisize the Pharmaceutical and Medical Division of Molex. The company offers innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Read more about Phillips-Medisize A/S at www.phillipsmedisize.com

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