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Design Control Engineer H/F - CDI (24)

Location: 

Sarlat la Caneda, FR

Job Family:  Research & Development
Country/Region:  France

Design Control Engineer H/F - CDI (24) 

Job summary

 

The Design Control Engineer drive the product risk management, design control, and usability activities 

He Contribute to product development activities on  IVS (innovation value stream)  and  SVS (Support value stream) based on highly qualified academic and/or technical development competences

The design Control Engineer support the Coloplast organisation with design control knowledge’s.

 

Responsibilities

 

  • Responsible for development tasks and activities based on experience, competences, and project needs. This includes planning, reporting and documentation of the work.
  • Plan and drive design control activities related to IVS and SVS projects . This includes responsibility of the Design Input and Output process and documentation on assigned project.

 

Product Risk management activities

 

  • Responsible for the Product Risk Management process and risk assessment documents for IVS and SVS on assigned projects such as Risk management plan, product risk assessment, Preliminary hazard analysis, product risk management report.
  • Establish best risk management practice for working in IU based on ISO14971 and related standard.

 

Usability

 

  • Responsible for the usability process and documents on assigned projects such as usability plan, user specification, task analysis and user interface analysis (inc procedure and template)
  • Responsible for formative and/or summative usability tests in assigned projects. This includes planning, recruiting, moderating, observing, analyzing and documenting tests.
  • Commission, coordinate and ensure execution of usability activities with external vendors.
  • Establish best usability management practice for working based on IEC 62366 and related standard

 

  • Contribute to improvement of existing procedures, systems or processes in Coloplast, especially within design control
  • Contribute to awareness of internal and external design control requirements (including requirements from relevant products standards) as well as good documentation practise.

 

Profile

 

  • Educational background: Master in Engineering, Pharmaceutical  or Life Science (E.g. Chemistry or Biochemistry)
  • Business experience in design control: 4 years
  • Experience from the medical device/life science industry
    Good knowledge of legislation, systems and procedures applicable to the medical device industry
  • Management experience necessary: None
  • International experience: preferred
  • Understanding of complex technical issues
  • Understand user needs and ability to transform these needs into technical solutions
  • Competence on IEC 60601, IEC 62304 and cybersecurity for medical device
  • Understanding of regulations, legislation, GMP and QA

 

  • Must have a reasonable level of scientific understanding within various fields, in order to drive design control activities at a high technical level.
  • Able to secure high level of quality, product safety and functionality in all relevant work processes
  • Proactive
  • Good communication skills in French and   English in verbal and written form
  • Tactical management of stakeholders
  • Use of internal and external networking for problem solving
  • Reach agreement through flexibility and compromis

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

 

Visit us on Coloplast.com.

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