Systems Engineer/Medical Device Technical Expert (RE2750)
Posted on Jan 7, 2021 by BRINE SA
BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.
Brine SA is looking for a Systems Engineer for our Client in Basel.
The Connected Health Ecosystems & Operations team is looking for an experienced System Engineer to lead the technical development of connected delivery systems including a medical device, mobile phone app and cloud based data storage. The ideal candidate contributes to the development of complex medical devices and software as a medical device (SaMD) projects using state-of-the-art system engineering practices. This highly interactive role will work with cross-functional teams and support various development activities including requirement elicitation, system conceptualization, risk assessment, system verification and clinical validation.
The primary responsibilities of System Engineer include:
- Design and implement systems engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices, digital technologies, and SaMD.
- Demonstrate strong technical know-how at system level and guide the project teams for product development on defining pain points, user needs and technical design input requirements.
- Structure and visualise the system using systems modelling tools and integrate into a wider eco-system.
- Utilize the system engineering tool for requirements management and translate user and business needs into system/sub-system requirements.
- Actively maintain and monitor the traceability from the requirements to the verification activities
- Implement risk management at systems level and co-ordinate risk management activities at component level.
- Write, implement and report on integrated system design verification and validation activities, especially in the area of end-to-end software testing.
- Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders.
- Author relevant design history files and GMP compliant documentations.
- Excellent problem-solving skills with an analytical mind.
- Systems and system of systems design using UML/SysML diagrams with good abstraction skills. Ability to decompose to device and software sub-systems. Domain modelling experience and linking to requirements definition and management a plus.
- Expertise in Web and Mobile application design, development and testing, as well as Cloud and IoT architecture and technologies for complex systems necessary, with application to SaMD.
- Detailed knowledge of using requirements management tools, previous experience of Polarion a plus.
- Prior experience of integrating and testing software modules developed by various teams is highly desirable.
- Knowledge of the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.).
- Experience with user experience, prototypes and proof of concept activities.
- Experience with cyber security, data privacy and system performance requirements.
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines
- Minimal 5 years of experience in medical device development, or other highly regulated industries
- Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders
- Prior experience covering the medical device and/or SaMD product development from concept to commercial launch
- Experience working with the requirements and traceability management tools
- Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA
Work location: Basel (remote work possible)
Duration: 4 to 6 months
Salary: to be discussed
Permit: EU permits
Ref. Nr.: RE2750
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2014