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Design Control Manager H/F - CDI (24)

Location: 

Sarlat la Caneda, FR

Job Family:  Research & Development
Country/Region:  France

Design Control Manager H/F - CDI (24) 

Job Summary

The Design control manager is responsible for all design control activities in general on IVS (innovation value stream) and SVS (Support value stream). He/she manages the design, the risk management of the products and supports the Coloplast organization with design control knowledge.

The Design Control Manager manage a team dedicated to this activity

 

Responsibilities

 

  • Manage the design control team and activities. This includes responsibility for the Design Input and Output process and documentation.
  • Ensure preparation of design control documents. Issue design specification and design verification and validation document. Support design review.
  • Lead a team of risk management specialist.
  • Insure alignment and rigors within the RMF process
  • Responsible for the Product Risk Management process and risk assessment documents for IVS and SVS  such as Risk management plan, product risk assessment, Preliminary hazard analysis, product risk management report. (inc procedure and template)
  • Lead a team of usability specialist responsible for establishing / contributing to usability engineering activities based on experience, competences and project needs. This includes planning, conducting, analyzing, and documenting the work.
  • Responsible for the usability process and documents such as usability plan user specification, task analysis and user interface analysis (inc procedure and template)
  • Contribute to the documentation in the usability engineering file.
  • Contribute to improvement of existing procedures, systems or processes in Coloplast, especially within design control.
  • Contribute to product development by implementing design control learnings through flexibility and compromise.

 

 

 

 

Job Qualifications

 

  • Educational background:
    Master in Engineering or PHD, Pharmaceutical or Life Science (E.g. Chemistry or Biochemistry)
  • Business experience:
    Experience from the medical device/life science industry : at least 8 years
    Good knowledge of legislation, systems and procedures applicable to the medical device industry
  • Management experience necessary: preferred
  • International experience: preferred
  • Understanding of regulations, legislation, GMP and QA
  • Notion on IEC 60601, IEC 62304 and cybersecurity for medical device
  • A good level of scientific understanding within various fields, in order to drive design control activities at a high technical level.

 

 

Competencies :

 

  • Strong leadership skills and organization navigation skills; ability to lead a cross-function team and deliver major projects within deadline
  • Excellent oral and written communication skills, both in English and French
  • A pragmatic mindset and the ability to find reasonable solutions
  • Agile and adaptable to change
  • Ability to consistently work and lead with ethical integrity
  • Passionate and a team player with strong self-awareness
  • Use of internal and external networking for problem solving
  • Reach agreement through flexibility and compromise
  • Willingness, ability and desire to learn

 

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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