Medical Devices Oem Services Risk Management
Bern, Switzerland
Job Description
\\n Ready to work with a highly innovative and fast growing Medical Device Developer and Manufacturer with innovative services for global pharmaceutical companies? Be the new Teamlead to support the product development process of customized applications in terms of RISK Management.
ISO 14971 emphasizes the need for a proactive and iterative approach to risk management, considering both known and foreseeable risks. Ongoing monitoring and evaluation of risks throughout the entire lifecycle of the medical device will be needed to thrive R&D forward. Compliance with ISO 14971 is a fundamental requirement, seeking regulatory approval for exciting new medical devices!
You and your team are viable business partners in this critical product development process and keep track on various influencing factors during Design Transfer, Verification and Validation, Evaluation of Process and Product Risks with FMEA tools, usability testing till final Tech Transfer of the Processes on site till delivery to the customer.
You are the interface between R&D, Industrialisation, Regulatory Affairs and customer stakeholders.
Your challenge:
ISO 14971 emphasizes the need for a proactive and iterative approach to risk management, considering both known and foreseeable risks. Ongoing monitoring and evaluation of risks throughout the entire lifecycle of the medical device will be needed to thrive R&D forward. Compliance with ISO 14971 is a fundamental requirement, seeking regulatory approval for exciting new medical devices!
You and your team are viable business partners in this critical product development process and keep track on various influencing factors during Design Transfer, Verification and Validation, Evaluation of Process and Product Risks with FMEA tools, usability testing till final Tech Transfer of the Processes on site till delivery to the customer.
You are the interface between R&D, Industrialisation, Regulatory Affairs and customer stakeholders.
Your challenge:
- Team leadership and litigation: risk management
- Personnel, cost and resource management
- Structuring systematic RISK determination in the product life cycle
- Definition and coordination of measures in project and product management teams
- Creation, guidance and supervision of risk analyzes for medical devices according to 13\\\'485 and 14\\\'971
- Degree in Mechatronics, Electronics, Software Engineering
- Experience life-cycle Management of highly innovative Medical Devices
- Knowledge of QA and Risk Assessment and relevant processes
- Experience with risk analysis and risk project management ISO 14\\\'971
- Strong communication skills for liasing across departments and external customers
- Project Management and direct leadership experiences
- C1 English language skills, B1-B2 German skills would be an asset
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Job Detail
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Job IdJD1611038
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBern, Switzerland
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EducationNot mentioned