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
- 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 skillsAbility to work closely with the project manager and drive action within the teamClearly communicate complex information especially with the management teamKnowledge of the medical device standards and regulations such as IEC 60601 or ISO 11608Desired Skills
Experience with using Modern Requirements or similar requirements management toolsExperience with using APIS or similar DFMEA toolsExperience with MatLab / SimulinkEducation and Work History Requirements
BS in ME, EE, SW, or Biomedical engineering is requiredAt least 10+ years of relevant experience in medical device developmentExperience managing entire design cycles from concept to productionThis is a contract position.
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