Contract position: Global leader in medical device manufacturing is currently looking a Engineer III-Systems Engineer in Roundlake IL. This is a contract opening expected to last 12 months, could be longer based on performance, possible temp to hire. Currently we are only looking for local candidates. Will consider various levels of experience. Great Contractor Benefits! Apply Now!Responsibilities for the Systems Engineer
Requirements for the Systems Engineer
- Contribute to the overall development of new features of medical infusion systems through the definition of system requirements, interface requirements, traceability and system verification.
- Propose solutions to technical challenges commonly associated with new product development
- Coordinating with EE, ME and SW functions within R&D as well as coordinating with Risk Management, Compliance, Reliability, Clinical, Human Factors, Marketing and Regulatory.
- Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications
- Direct testing and analysis of system requirements
- Develop the Risk Management Plan and execute the Risk Management activities defined by the plan
- Manage integration of deliverables from sub-system design teams and external partners
- BS in Engineering (Mechanical, Chemical, Bioengineering, or Biomedical)
- 3+ years systems engineering project experience (requirements development, requirements management, design, or verification) in the medical device or pharma industry
- 2+ years experience with the development and verification of electronic medical equipment with embedded firmware.
- Experience with Medical Device design controls and understanding of Good Document / Manufacturing Practices in the area of design controls, including FDA-21 CFR 820.30 and ISO 9001.
- Working understanding of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- DOORs or ALM
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.