July 5, 2016
Location : Lake Forest, IL
Performs professional engineering work in the integration of system components to meet product requirements.
Systems Engineer responsible for New Product Development and Sustaining Engineering DHF documentation in accordance with CFR 820.30 and corporate procedures.
Contract Systems Engineer, DDD:
The Systems Engineering function has primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also post-market maintenance activities such as risk assessment, change management, and technical support for regulatory inquiries.
This position is responsible for end-to-end product life cycle management including project planning, creating and maintaining product requirements and risk files, establishing and publishing traceability, and providing for on-market support and maintenance. In compliance with CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions, and may also be responsible for on-market product documentation.
Engineering degree required.
Experience required: Systems Engineering, DHF, Design Controls, Risk Analysis, CFR 820, ISO 14971
Essential Job Functions:
The incumbent must be able to perform all of the following duties and responsibilities with or without a reasonable accommodation.
– Determines the DHF Structure and Owns the Requirements and Risk Management File.
– Primary responsibility for DHF content generation in support of regulatory submissions with compliance to governing procedures and CFR 820.30
– Partner with other functions in the organization to ensure stakeholders’ requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and to instill a spirit of collaboration throughout the organization.
Other Duties and Responsibilities:
The incumbent may perform all or some of the following duties:
– Partner with department team members on process improvements that support greater efficiencies.
– DHF compliance, change management, risk assessments, and regulatory inquiries for on-market product.
– Completes activities as necessary to maintain systems engineering documents as new information is learned during the development process or per information obtained through post market surveillance programs.
– Perform other related duties as assigned or required.
ICONMA is a nationwide consulting firm with corporate headquarters in Troy, MI, providing Professional Staffing and Project Based Services and Solutions for Fortune 1000 clients in a broad range of industries. Core Industries served include: Biotech/Pharmaceutical, Cable, Clinical, Consumer Services, Energy, Engineering, Financial Services, Food & Beverage, Government/Defense, Healthcare, Insurance, Logistics, Manufacturing, Media, Mortgage, Oil & Gas, Pharmaceutical, Retail, Scientific, Services, Technology, Telecommunications, Transportation, and Utilities.
ICONMA is a certified Woman-Owned “Woman-Owned Business Enterprise”, certified by Women’s Business Enterprise National Council (WBENC) and National Women Business Owners Corporation (NWBOC).
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner.
We measure success by the results of our customers. As a business partner, we know that world-class service and cost effective solutions are the primary keys to success. ICONMA uses technical expertise and business knowledge to help customers achieve these objectives.
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