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Process Developer Medical Device

  • Location: Münchendorf, 80331
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 9 Tage her

Manager / Sr. Manager Prozessentwickler/Process developer (m/w/d)

Based in Munich, our client is an international company involved in the development, production and distribution of medical devices.

Our client is currently looking for a candidate for development and implementation of manufacturing processes.

If you are looking for a new challenge and are familiar with process development, I am looking forward to our conversation.

Your tasks for this position:

  • Preparation of work and testing instructions and implementation of training for production personnel
  • Development and implementation of manufacturing processes for the production of complex medical devices
  • Creation, detailing, implementation and documentation of state-of-the-art manufacturing and testing concepts in accordance with regulatory requirements and SOPs for sterile disposables
  • Process development during the product development process with subsequent evaluation of different solution variants and economic feasibility studies in preparation for investment decisions
  • Layout and process flow planning of production areas and workplaces, taking into account lean production methods and the application of GMP and GAMP-5
  • Definition of criteria for the evaluation and approval of production processes
  • Definition and qualification of required process equipment and measuring devices both internally and at external suppliers and development partners
  • Definition of specifications for process and test method validation
  • Application of statistical methods
  • Preparation of process validation plans for plant qualification, process validation and test method validation
  • Identification of optimisation opportunities for existing production processes and implementation of corresponding measures
  • Cross-functional cooperation with the development, production and quality management departments throughout the entire product life cycle
  • Determination and definition of critical process parameters as well as implementation of risk assessments and process FMEAs

What is expected

  • Several years of professional experience in production process development of sterile disposables in the highly regulated working environment of medical technology
  • Extensive experience in process (IQ, OQ, PQ) and software validation
  • Distinct lean methods and CIP management competence
  • Knowledge of plastic injection moulding in the medical technology sector
  • Strong sense of responsibility, cost and quality awareness
  • Convincing, communicative personality with a high degree of assertiveness and organisational talent
  • Very good written and spoken German and English skills
  • Analytical, structured and solution-oriented way of working
  • Successfully completed studies in the field of medical technology, mechanical engineering, industrial engineering or similar
  • Collaborative work style and enjoy working in cross-functional teams

Application process

  • Curriculum vitae to my e-mail:
  • Telephone call with presentation of the company
  • I am your contact person for the entire application process (interviews to contract negotiations) i.e. you do not have to apply yourself
  • Discussion of other exclusive positions that fit your profile

My contact details

I am looking forward to your application!