Systems Engineer

Engineer II

Duration: 6 Months Location: Fully onsite during training– then hybrid, Lake County, IL Pay Rate starts at: $55/hr

Client is looking for a Systems Engineer to join their Product Development, Sciences and Technology team in Operations. This individual will contribute to the development and launch of new commercial drug / device combination products. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people's lives. As a Systems Engineer, you will be responsible for integration of inputs and risks from multiple disciplines to ensure the development of a robust patient-centric product design and with reliable performance.

Core Job Responsibilities

You will be a core member of the combination product development team responsible for the implementation of appropriate product development engineering principles within the Design Controls process with particular focus on Design Inputs, Risk Management, Traceability, and Design Validation. It is expected that the engineering activities for which you will be responsible may be done internally and externally. The external engineering activities will require you to develop and foster relationships with Engineering Services firms and third-party development partners who may be in Europe, Asia, and US, and in addition to regular teleconferences, will require periodic face-to-face visits.

You will be responsible for driving the following activities/deliverables:

• User and Stakeholder Needs Definition
• System/Sub-system Requirements Definition
• System Architecture & Integration
• Use Case Analysis
• Traceability
• Standards Coverage Analysis
• Risk Management Planning and reporting
• System Risk Assessment
• Use Related Risk Assessments
• Integration of Third-Party and Drug Product Development activities
• Design Validation Planning, protocols, and reports

Flexible Assignment Responsibilities

Lab Support: Execute test protocols supporting exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Experience using Zwick (UTM), machine shop equipment, 3D printers is required. Familiarity with fixture development, volumetric accuracy equipment, viscometers, climate chambers, etc. is a plus.

Test Methods: Develop, validate, and transfer test methods.

Design Verification: Author verification protocols and reports. Support investigations and issue resolutions.

Software Tools: Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred. Experience with Minitab and Matlab is a plus.

Work in an independent manner under the guidance of a supervisor or technical lead. Complies with applicable policies and procedures, regulatory and safety requirements.

Qualifications

You will be responsible for providing technical leadership in your areas of responsibility and ensuring the systems design and documentation meet all safety and global regulatory compliance requirements. It is expected that you will work with the development team to resolve key project hurdles and to identify, communicate, and mitigate project risks.

Expertise in product development from initial concept to release to market is required with experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred. Expertise in various Systems Engineering activities including user and stakeholder need definition; requirements definition and management; risk management, product architecture, configuration management, traceability, change management and design validation.

The candidate must have strong analytical and communication skills and should be self-driven. It is expected that you will continuously look for opportunities to simplify the ways we work to enable development efficiency without compromising quality. This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness will help make you successful in this position.

Experience: BS in Engineering, Science, or closely related discipline with 3+ years of experience or MS or higher with 2+ years of experience Ability to multitask and work within timelines. Demonstrated scientific writing skills and strong verbal communication skills. Position will be hired based on level of experience.