Eindhoven, The Netherlands
Posted 1 month ago

Brainbox Consulting BV aligning great talent with clients’ needs is at the core of who we are. We are passionate about our Consultants, our Clients, and our Partners. Our rich IT legacy combined with our unyielding care for our people and business is the driving force behind all we do, and we deliver! On this journey, we are looking for a Product/ System & PLM Engineer who oversees health programs from start to finish and achieve organizational health goals.

Responsibilities:

  • Manage the traceability between design artifacts (e.g., FMEA, Requirements) to ensure clear documentation of the MUSA-3 system.
  • Support the system architect in defining reliability tests and work with the verification team to facilitate testing.

Ideal Candidate:

  • Experienced in medical devices and relevant standards (ISO 13486, ISO 14971, IEC 60601).
  • Proficient in using requirements management tools (e.g., IBM ELM, Jama, Cognition Cockpit).
  • Knowledgeable in risk management and FMEA processes.
  • Experienced in life/reliability testing.

Skill Summary:

  • Experienced systems engineer
  • Understanding of MedTech standards
  • Traceability tools experience (Jama preferable)
  • Understanding of risk management and FMEA processes
  • Experience with life/reliability testing

Job Features

Required SkillsSystem engineering, ISO 13485, ISO 14971, IEC 60601, Jama, FMEA, Risk management, MedTech Standards

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