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System Engineer SAMD - medical device development

RM IT Professional Resources AG

Posted on Jan 9, 2021 by RM IT Professional Resources AG

Basel, Switzerland
Engineering
Immediate Start
Annual Salary
Contract/Project


System Engineer SAMD - medical device development vacancy for a globally operating Basel based company in the pharma sector.

Your experience/skills:



  • 5+ years of work experience in the medical device development field or other highly regulated industries

  • Expertise with covering medical device or SaMD product development from concept to commercial launch as well as with cyber security, data privacy and system performance requirements

  • Good understanding of system design using UML or SysML diagrams with solid abstraction skills and the ability to decompose to device and software sub-systems along with expertise in Web and Mobile application design, development and testing plus Cloud and IoT architecture

  • Proficiency of working with the requirements and traceability management tools paired with excellent communication skills for technical discussions with the dev team and for alignments with business stakeholders

  • Familiarity in medical device or SMD development, Quality Management System and regulatory processes including different ISO and IEC

  • Higher degree in Biomedical Engineering, Systems Engineering, Electrical or Electronic Engineering, Computer Science or any other relevant discipline

  • Languages: English, fluent in written and spoken


Your tasks:



  • Planning and implementing a systems engineering approach, supporting the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices, digital technologies and SaMD

  • Proving excellent technical know-how at system level and guiding the project teams for product development on defining pain points, user needs and technical design input requirements

  • Organizing and visualizing the system using systems modelling tools and integrating it into a wider eco-system

  • Applying the system engineering tool for requirements management and translate user and business needs into system and sub-system requirements

  • Implementing risk management at systems level and coordinating risk management procedures at component level

  • Documenting of relevant design history files and GMP as well as maintaining and observing the traceability from the requirements to the verification activities

  • Acting as the representative of system engineering for the communication with cross-divisional teams, programs and stakeholders


Start:
Duration:
Location:
Ref.Nr.:
02/2021
06MM+
Basel, Switzerland
BH16456

Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

New to Switzerland? In case of a successful placement, we support you with:



  • All administrative questions

  • Finding an apartment

  • Health- and social insurance

  • Work permit and much more


Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.




Reference: 1055323914

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