Vor Ort
02/2016 vorerst
ITech Consult
flag_no Schweiz

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Luzern und Region
Job Type:
Bis Ende Februar 2016 (vorerst)
Für unseren Kunden im stark regulierten Umfeld (Grossraum Zürich/Luzern) suchen wir ab sofort einen Konfigurationsmanager.
Within the medical device industry we are looking for a Configuration Manager to support a diagnostic instrument development project consisting of > 100 team members. The responsibility of the position covers the standard activities of configuration management for the instrument according to ISO 10007, which are in detail:
Configuration Management Tasks during Product Update Activities

. Clarification of the impacts on hardware and software interfaces and of the compatibility with the software as well as documentation within configuration notes.
. Provide Configuration Reports about instrument configurations on request of project stakeholders
. Provide project milestone documentation
Configuration Management Tasks during Product Care Activities

. Contact person for the client's configuration management requests and participation in the client's configuration management meetings
 . Participating in the product team meeting which is scheduled and led by the product manager from the instrument production
(task "Configuration Management Impact Clarification" for each instrument change)
(challenge the decisions about installed base upgrades and retrofits)
. Release of reference configuration baselines on the basis of their approval in the product team meeting
(update of SAP reference baselines and handover to the client)
(update of baseline documentation and information of all stakeholders)
. Responsible for clarification of the impacts on the hardware and software interfaces and compatibility with the software
. Interface to the client's configuration management
(responsible for baseline definition)
(installed base transfer into SAP)
(checking of data integrity)
. Coordination and monitoring of internal retrofit activities
(retrofit coordination with in-house support & client support)
(cost monitoring)
(performance reporting)
(relevant documentation)
. Maintenance of the configuration baseline structure
(Change Tracking Tool: data analysis and update of installed bases for instruments as well as application of configuration sticker on the accordingly updated instruments)
. Release documentation: hardware release notes & configuration notes
. Provide Configuration Reports about instrument configurations on request of project stakeholders, eg
(information about performed retrofits)
(development states of configuration items)
(actual firmware versions)
("where used" analysis
. Maintenance of change tracking tool, application and server as well as responsible for further toll development and stabilization (interface with other system projects)
. Responsible for SAP data storage & analysis of functions and clarification of SAP related issues and developments
(Creation and transfer of configuration trees within the production)
. Update of configuration management plan
. Contact person in case of questions about the project specific configuration management process
Required Skills:
. Degree in a relevant engineering discipline, eg mechatronic, technical informatics or related field (advanced degree preferred) and strong affinity with hard- and software.
Further education
. Ideally CM II professional
Work experience
. Up to 3 years' experience in configuration management in complex medical Leadership skills to lead the hardware & software configuration managers.
. device development projects (hardware, software), preferably in the diagnostic industry.
. Experience in working in a regulated environment (eg FDA, ISO 13485 etc.)
. Ability to work in an interdisciplinary environment and manage technical interfaces pro-actively
. Strong in influencing others and solid communication skills - ability to clearly convey the benefit of configuration management
. Able to work independently as well as in a team, especially in a team with indirect reporting relationships
.Strong computer skills with advanced competence in excel, SAP and/or other Enterprise-Resource-Planning systems
- Sehr gute Deutsch- sowie Englischkenntnisse (mündlich und schriftlich)