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Hiring: Systems Engineer (Requirement Engineer)

We are looking for a proactive systems engineer (requirement engineer) with expertise in product lifecycle management and medical device standards & regulations. You want to work with an ambitious team, Join us today!

Apply now!

WHO ARE WE

Decos digitizes the world. From our paper and management less offices, we work in self-managing teams, where you determine your goals and the ways in which you will achieve them. You will enjoy your coffee with your future colleagues.

We create IT solutions that allow you to work effectively and efficiently. We do this for governments as well as for private enterprises so that they can better tailor their services to the needs of their residents. For example, we are working on Smart Cities, with smart software that meets today's contemporary digital needs. With beautiful web forms and easy apps, we try to make it so nice and simple for people that applying for an event permit or reporting storm damage is a breeze for everyone.

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 62304
  • 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 14971, IEC 60601-1, 60601-1-2, 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
  • Enthusiastic colleagues

Are you the colleague who challenges himself to achieve good results? Send your CV and motivation letter to Anita Swarup and tell us why you are a valuable addition to Decos. Our colleagues would like to welcome you to our building!

Send an email
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