System Analyst / Engineer (KR2828)
We are looking for a person who can:
Design and implement risk management approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices and medical device software including SaMD.
Use tools such as Polarion for capturing risk management data and generating the necessary documentation, as well as tracing hazards and risks from system to component level maintain and monitor the traceability from the requirements to the verification activities
Integrate information security risk management requirements into the risk management process such as cybersecurity and data privacy.
Write and maintain risk management plans, hazard analyses and design FMEAs.
Update risk files based upon real-world evidence from clinical and commercial products.
Be the risk management representative for communications with cross-divisional teams, programs, and stakeholders.
Author relevant design history files and GMP compliant documentations.
has an excellent problem-solving skills with an analytical mind.
You should have:
Prior experience covering the medical device and/or SaMD product development from concept to commercial launch
Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485, ISO 14971, IEC 60601, 62304, 82304)
Expertise in medical device development and life-cycle regulations with a focus on risk management.
Minimal 5 years of experience in medical device development, or other highly regulated industries
Ability to decompose to device and software sub-systems. Domain modelling experience and linking to requirements definition and management a plus.
Expertise in SW development and SW architecture a plus, as well as cyber security and data privacy a plus.
Start Date: asap
Duration: to end of year
Location: Basel, Switzerland
Salary: To be discussed
Apply now
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Zurich
Selnaustrasse 2
8001 Zurich
Switzerland
Tel: +41 44 406 10 00
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Lausanne
Voie du Chariot 3
1003 Lausanne
Switzerland
Tel: +41 22 566 19 00
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Basel
Teichgässlein 9, 5th floor
4058 Basel
Switzerland
Tel: +41 61 311 66 90
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