Systems Design Engineer

Contract: North Chicago, Illinois, US

Salary: $47.00 Per Hour

Job Code: 355137

End Date: 2024-11-21

Days Left: 28 days, 23 hours left

Job Description:
 
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.
Job Requirement
  • Test Methods
  • Design Validation
  • System Architecture & Integration
  • Minitab/Matlab
  • Design Verification
  • Risk Management
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Vishnu Nair
  • vishnu.nair@collabera.com
Apply Now
Apply Now
close-icon

Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

Consultant Login
About
Resources
Phones Email

Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

Consultant Login

©2024 Collabera. All rights reserved.