Beschreibung
System Engineer
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.
We are looking for a System Engineer, for one of our customers in Basel.
JOB DESCRIPTION:
The Packaging and Device Development (PDD) department in our firm is looking for an experienced System Engineer. The System Engineer will contribute to the development of best-in-class system engineering practices and its implementation to medical device and/or software as medical device (SaMD) development projects. The preferred candidate has practical experience covering the product development to the life cycle management. The expert will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation.
The primary responsibilities of System Engineer include:
Design and implement system 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 development team to use structured system engineering approach for product development
Utilize the system engineering tool for requirement 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
Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders
Manage external vendors for development and lead the technical discussions with the vendors
Author relevant design history files and GMP compliant documentations
Qualification
Track record of going through the product development cycle, from prototype to commercial launch, in the medical device industry or GMP environment is highly valued
Good knowledge in systems engineering approach and risk-based approach for product development
Experience working with the requirements and traceability management tools
Knowledge in system functional modelling and/or programming ability using system modelling language (SysML) will be a plus.
Experience in developing and commercializing products using artificial intelligence or machine learning models is a strong advantage
Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
A good team player, and problem solver with strong analytical mind
Strong communication skills to both lead the technical discussions with vendors and also align with internal stakeholders to drive decisions
Additional: Most important skills? Specialized and able to provide technical leadership in one of the following areas: cloud/Back End server architecture, AI/ML algorithms, software/APP development as medical device (SaMD)
More for architecuring and interfaces?
Ability to architecting the system, define the interface between sub-systems and coordinate the overall project activities at technical level
MUST HAVES:
1. Understanding of medical device standard/regulations (ISO13485, 21 CFR part 820, IEC 62304).
2. Practical experience working in Medtech industry.
3. Strong technical expertise in one of the engineering fields or technical areas mentioned above in JD.
4. expertise in cloud server/APP development in medical device field or other regulated environment
5. experience as a software architect in medical software
Pharma experience is not mandatory. However work experience in medical device industry is highly desirable.
Extension into next year is highly probable. The team has strong need to recruit more System Engineers to support upcoming projects next year.
No remote work doable at the moment.
EDUCATION:
Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electronic Engineering, Computer Science, or other relevant disciplines
Work location: Basel
Start:
Duration: 1 year
Workload: 100%
Salary: to be discussed
Language: English
Ref: EW2619
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA
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
Pharmaceutical industry
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