Systems Engineer Risks and Safety Standards

Systems Engineer Risks and Safety Standards
Systems Engineer Risks and Safety Standards: Product Development / Critical Risk /Safety Standards / documentation / Medical Devices / IVD devices / quality process compliance / English / German
Background:
In the field of Near Patient Care, we are shaping the future of diagnostics directly at the patient's side.
We are looking for a systems engineer who is passionately committed to designing reliable products and to maintaining compliance throughout the product lifecycle. As a part of our Standards & Product Risks team, you will ensure the safety and performance of our medical and IVD devices.
The Perfect Candidate:possesses extensive expertise in medical device system development, with a deep understanding of compliance for critical risk and safety standards, including ISO 14971, IEC 60601-1, IEC 61508, and IEC 62304. They offer comprehensive experience across the systems engineering lifecycle-from requirements engineering to architecture, system integration, usability engineering and verification & validation (V&V). Furthermore, they demonstrate proficiency in risk management, safety/reliability engineering and product lifecycle management, alongside a proven ability to rapidly master complex technologies and navigate rigorous regulatory documentation.
Tasks & Responsibilities:
Organize and execute failure mode and effects analysis with a team of engineers
Identify hazards and risks in context of product risk management
Revise HW & SW system safety and reliability concepts, incl. functional safety
Oversee execution and documentation of tests within the certification board scheme (CB report)
Update and provide corresponding documentation according to internal and external standards
Workpackage and task planning & reporting to project stakeholders
Must Haves:
A degree in Electrical/Mechanical/Software engineering, Physics or similar
More than 3 years experience in product development
GMP experience, experience with Design controls, good documentation practice, design transfer, risk management and quality process compliance
Fluent English
Nice to Haves:
German
Reference Nr.: 925173
Rolle: Systems Engineer
Industrie: Pharma
Location: Rotkreuz
Pensum: 100%
Start: Latest start date()
Duration: 12 + Months
Deadline:
If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: .
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. jidf917095a jit0834a jiy26a