Systems Engineer - Intellectt INC

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.

• 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

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

• 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

• 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 They work with companies like Medtronics and Eli Lilly to develop and manufacture first generation and second generation medical devices based on what Medtronics and Eli Lilly are looking for.
• The products the Systems Engineer will be working on range from Body Injectables to Insulin Pumps, to Fluid Containers and can include Springs, Motors, and Needles in the specs.
• They are also working on a blood analyzer with the current size of a refrigerator that they are going to be working down to the siz of a table.
• In addition to traditional Systems Engineering responsibilities, Jabil's Systems Engineers also act as technical leads and help the Project Managers with technical alignment (acts as a technical compliment) to establish a development approach and drive and level set the software, verification, electrical, and mechanical project leads.
• Any experience with JAMA or Azure DevOps is helpful because that is the tools their requirements are written in - these are nice to have and the manager is not worried about requirement tools.
• ISO 11608 or IEC 60601 are critical.

Remark

• Need Systems Engineer - 8 to 10 + years of experience.
• The products the Systems Engineer will be working on range from Body Injectables to Insulin Pumps, to Fluid Containers and can include Springs, Motors, and Needles in the specs.
• They are also working on a blood analyzer with the current size of a refrigerator that they are going to be working down to the size of a table.
• Jabil needs a Systems Engineer that has previous experience creating and translating requirements in the Medical Device Industry. A heavy emphasis and lean towards a Systems Engineer with a mechanical or electro/mechanical background. They will be concentrating on developing block, interface and interaction diagrams.
• In addition to traditional Systems Engineering responsibilities, Jabil's Systems Engineers also act as technical leads and help the Project Managers with technical alignment (acts as a technical compliment) to establish a development approach and drive and level set the software, verification, electrical, and mechanical project leads.
• This is an onsite position in St. Petersburg Florida. There will be some flexibility, but most of the team works exclusively out of the office as a result of the nature of the work.
• Any experience with JAMA or Azure DevOps is helpful because that is the tools their requirements are written in - these are nice to have and the manager is not worried about requirement tools.
• ISO 11608 or IEC 60601 are critical. If a candidate does not have experience with either of these, probably not going to be the right fit.