Job Title: Systems Engineer (Medical Devices)

Location: St. Petersburg, FL

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