Principal System Engineer | Enea Romania | 0LOVES1
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We're not saying it's gonna be easy.
But we promise it's not gonna be boring.

We pride in providing new challenges all the time for our creative, rebellious engineers. This is the kind of place where we want to change the world with the right lines of code. Insane passion, curiosity and thirst for breaking barriers and rules feel like home here at Enea.

Would you feel like home?

Principal System Engineer

Location: Bucharest/Iasi, Romania

Number of positions available: 0

Job Type: Full Time

Division: Services Division, Enea Romania

We pride in providing new challenges all the time for our creative, rebellious engineers.
This is the kind of place where we want to change the world with the right lines of code. Insane passion, curiosity and thirst for breaking barriers and rules feel like home here at Enea. Would you feel like home?
 

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Job description

Position objectives

This role is for our client from US, involved in medical diagnostics area and will lead requirements analysis, traceability, hazard analysis and risk management activities for our next generation of portable diagnostics platforms product software in one or more projects.
Few details about the client: family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. A global leader in rapid point-of-care diagnostics, the products, as well as the new product development efforts are focus on infectious disease, cardiometabolic disease and toxicology.

Essential functions

  1. Gather needs from different stakeholders and translate them into a system design and system requirements
  2. Identify system and subsystem level interfaces and document these into interface protocol requirements
  3. Create and maintain system traceability among needs, system, sub-system level requirements and risk management
  4. artifacts to ensure completeness and fully traceable design history file

  5. Responsible for some or all of the following deliverables: Requirements Management Plan, Requirements Analysis, User Needs, System Requirements, Subsystem Requirements, Risk Management Plan, Risk Analysis, Evaluation and Control, Preliminary Hazard Analysis, Device Hazard Analysis, Fault Tree Analysis, FMEA, Risk Management Reports
  6. Understand and be aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Required key skills

  1. Strong interpersonal, communication skills, analitical skills and presentation skills; Good command of English
  2. Experience writing Use cases, creating Storyboards and using Voice-of-Customer (VOC) techniques to facilitate requirements gathering efforts (Interviews, Surveys, KJ Analysis, CTQ, AHP, Kano Analysis, and Critical Parameter management)
  3. Ability to moderate requirements engineering discussions and work as a bridge among different engineering departments and global stakeholders
  4. Expert level requirement elicitation, analysis and documentation skills

Qualifications

  1. Bachelor of Science (M.S. preferred) in Biomedical Engineering, Electrical Engineering, or equivalent, including relevant coursework and/or work experience in product development
  2. 8+ years of experience in product development (comprising electro-mechanical and software pieces)
  3. Proficient with Medical Device regulations (IEC 62304, 21 CFR part 820.30-Design Controls)
  4. Familiarity with Human Factors and Usability Engineering standards and guidelines (AAMI/ANSI HE75, ISO/IEC 62366, UCM 259760)
  5. Experience architecting and allocating requirements across multiple subsystems
  6. Experience with Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA)

Great to have

Experience setting up, configuring and using enterprise requirements management systems (e.g.: Jama, IBM DOORs, Polarion) is a plus.

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