Medical Device Technical Expert
Posted on Jan 6, 2021 by RM IT Professional Resources AG
Medical Device Technical Expert vacancy for a globally operating Basel based company in the pharma sector.
- 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
- 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
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.
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