Systems Engineer (Medical Devices) (FL)
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
Department: Preferred Vendors
This is a contract position
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