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Lead Expert App Development
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Design, Engineering
Projektbeschreibung
Lead Expert App Development wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- MSc/MA in Computer Science or other relevant field with 7+ years' experience in technical Project Management with a complex structure and safety critical applications in a regulated environment, ideally in pharmaceutical development
- Proficiency in designing innovative software and system architectures, coupled with good understanding of current Agile development methods and technologies
- Excellent knowledge of software design and programming principles as well as in overall verification strategies, including test set-up and test automation
- Strong background in developing and writing technical documentation of drug/device combination products and medical devices, including design control and other applicable regulatory, QA and GMP aspects as well as general understanding of Human Factors Engineering, Risk Management, Clinical Studies Processes and Stakeholder Management
- Know-how of medical device regulations, such as FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulations and IEC 62304
- Languages: fluent English and German both written and spoken
YOUR TASKS:
- Leading the software development of mobile and web applications and providing software and systems life cycle expertise within a broader cross-functional drug product development team
- Supporting the standardisation of the entire life cycle management process in order to utilise cross-product synergies
- Leading the collaboration with external development partners to support supplier selection, auditing and approval as well as elaborating development plans and monitoring work progress according to plan
- Monitoring, supporting and challenging technical development and deliverables as well as change, test and release strategies
- Deploying and implementing a sustainable Product Life Cycle process in addition to supporting cross functional project teams during development, review and submission of regulatory dossiers
- Leading risk management activities, authoring technical documentation as well as planning and monitoring design verification activities and ensuring a high quality Design History File
START: 01/2019
DURATION: 12MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13745
Does this sound like an interesting and challenging opportunity to you?
Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
YOUR EXPERIENCE/SKILLS:
- MSc/MA in Computer Science or other relevant field with 7+ years' experience in technical Project Management with a complex structure and safety critical applications in a regulated environment, ideally in pharmaceutical development
- Proficiency in designing innovative software and system architectures, coupled with good understanding of current Agile development methods and technologies
- Excellent knowledge of software design and programming principles as well as in overall verification strategies, including test set-up and test automation
- Strong background in developing and writing technical documentation of drug/device combination products and medical devices, including design control and other applicable regulatory, QA and GMP aspects as well as general understanding of Human Factors Engineering, Risk Management, Clinical Studies Processes and Stakeholder Management
- Know-how of medical device regulations, such as FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulations and IEC 62304
- Languages: fluent English and German both written and spoken
YOUR TASKS:
- Leading the software development of mobile and web applications and providing software and systems life cycle expertise within a broader cross-functional drug product development team
- Supporting the standardisation of the entire life cycle management process in order to utilise cross-product synergies
- Leading the collaboration with external development partners to support supplier selection, auditing and approval as well as elaborating development plans and monitoring work progress according to plan
- Monitoring, supporting and challenging technical development and deliverables as well as change, test and release strategies
- Deploying and implementing a sustainable Product Life Cycle process in addition to supporting cross functional project teams during development, review and submission of regulatory dossiers
- Leading risk management activities, authoring technical documentation as well as planning and monitoring design verification activities and ensuring a high quality Design History File
START: 01/2019
DURATION: 12MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13745
Does this sound like an interesting and challenging opportunity to you?
Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik