Systems Engineer (Requirement Engineer)
Decos Global
south Holland, NL
5 dagen geleden


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.

    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
  • Enthusiastic colleagues
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