Cedent
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
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