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Systems Engineer (Medical Devices)

CEDENT

FL

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JOB DETAILS
SKILLS
Application Programming Interface (API), Architectural Analysis, Communication Skills, Component Selection, Customer Relations, Design Failure Mode and Effects Analysis (DFMEA), Environmental Design, Hardware-Software Integration, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), MATLAB, Manufacturing/Industrial Processes, Medical Equipment, Medical Protocols, Process Development, Product Testing, Product/Service Launch, Prototyping, Quality Assurance Methodology, Regulations, Requirements Management, Risk Analysis, Risk Management, Root Cause Analysis, System Architecture, Systems Engineering, Team Player, Technical Leadership, Test Plan/Schedule
LOCATION
FL
POSTED
30+ days ago

Job description:

The System Engineer will provide technical leadership and oversight for the development of new medical devices developed in conjunction with our client's customer partners in a fast-paced environment.  The System Engineer will develop systems engineering deliverables such as requirements, product architecture, and risk analysis and be a key team member working closely with the customer’s team. The ideal candidate will have a successful track record of leading technical product
development teams and launching products into production.

Job Responsibilities

  • Requirements management and development
  • System architecture definition including interface definition and interaction diagrams
  • Risk Management including DFMEA
  • Concept Development including evaluation and selection
  • Technology / key component selection
  • Oversee HW/SW integration
  • Work with product verification team for test method development
  • Participate in prototype build activities
  • Root cause investigation of technical issues
  • Be customer facing and interface with the customer’s technical team

Required Expertise

  • Solid critical thinking and decision-making skills
  • Ability to work closely with the project manager and drive action within the team
  • Clearly communicate complex information especially with the management team
  • Knowledge of the medical device standards and regulations such as IEC 60601 or ISO 11608

Desired Skills

  • Eco-design techniques a plus
  • Experience with using Modern Requirements or similar requirements management tools
  • Experience with using APIS or similar DFMEA tools
  • Experience with MatLab / Simulink
  • Manufacturing process development

Education and Work History Requirements

  • BS in ME, EE, SW, or Biomedical engineering is required
  • At least 10+ years of relevant experience in medical device development
  • Experience managing entire design cycles from concept to production

About the Company

C

CEDENT