WE ARE LOOKING FOR
Systems Engineer (Requirement Engineer)
Must have competencies :
Proven 5-8 years of experience as a Systems Engineer in Medical Devices domain.
Knowledge of requirements traceability and generating trace matrix.
Knowledge of electronics engineering and related processes, preferably in the Medical Device domain
Knowledge of IEC
Experience with requirements management tools such as Jama and DOORS
Experience with auditing and reporting procedures
Understanding of Healthcare / Medical Devices domain related compliance standards and regulations
Analytical mind with problem solving aptitude.
Excellent communication and presentation skills.
Experience with ISO , IEC -1, -1-2, FDA CFR, EU MDR regulations.
Experience with CAPAs and DHF remediation.
Knowledge of product lifecycle management.
Experience with requirements specification and traceability.
Product requirement engineering
Experience in Gap Analysis
Technical Requirements (Good to Have) :
Knowledge of risk assessment and control.
Professional Risk Manager (PRM) certification is a plus.
Experience of working on Agile projects.
Experience of working with distributed agile teams in offshore / onsite model
Soft Skills (Must Have) :
Excellent communication & presentation skills
Positive attitude towards learning / challenges / team / etc.
Good team player / team leader / coach / mentor
Essential Duties & Responsibilities :
Analyze and extract system requirements and generate a System Requirements Specifications
Support Electronics Architecture Design in agreement with System Requirements
Strong cooperation with hardware and software engineers
Support creation of Software and Hardware Requirements Specifications incl. traceability to System Requirements
Support System Test Specifications and traceability to requirements
Working with third-party test labs for safety and EMC testing & packaging, handling, and environmental testing
Prepare reliability analysis plans and analyses
Identify part information and perform analysis for biocompatibility evaluation assessments
Comply to process requirements and meet standards.
WHAT’S IN IT FOR YOU?
You receive the opportunity to work in an international environment in a fast-growing software company.
A lot of room for personal initiative
Plenty of opportunities for personal development
A pleasant informal and inspiring work atmosphere