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Onsite Coordinator

Job in Chicago, Cook County, Illinois, 60290, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-01-12
Job specializations:
  • Engineering
    Mechanical Engineer, Product Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

Job Description

Experienced Mechanical Design & Manufacturing Engineer with proven expertise in the design, development, and validation of plastic, casting, and sheet metal components including mold design. Adept at managing end-to-end product engineering operations from concept through manufacturing, ensuring design quality, manufacturability, and compliance with industry standards such as IP6X, UL, and IEC. Skilled in coordinating cross‑functional teams, conducting feasibility reviews, and leading global collaboration for new product introduction.

Responsibilities
  • Lead design and development of mechanical systems including plastic, casting, and sheet metal components with focus on manufacturability and cost optimization.
  • Prepare detailed manufacturing drawings, assembly instructions, BOMs, and engineering documentation (DHF, DMR, design change plans, impact analysis, etc.).
  • Collaborate with hardware, firmware, verification testing, and mechanical design teams to ensure seamless integration of design requirements.
  • Develop and track project requirements, plans, and timelines; conduct weekly engineering follow‑up meetings with offshore and onsite teams.
  • Drive Design Specification Reviews (DSR) with suppliers, ensuring adherence to technical, cost, quality, and schedule targets.
  • Perform design feasibility assessments, DFMEA preparation, and verification/validation planning in compliance with medical design control processes.
  • Coordinate prototype builds, verification testing, and supplier interaction for proof‑of‑concept (POC) manufacturing.
  • Conduct tolerance stack‑up analysis to validate design specifications and ensure functional performance.
  • Collaborate with analysis teams on fluidic simulations, thermal studies, and finite element analysis (FEA).
  • Ensure risk assessment and mitigation throughout the design lifecycle.
Requirements
  • Bachelor's or master's degree in mechanical engineering, Manufacturing Engineering, or related discipline.
  • Proven experience in plastic, casting, and sheet metal component design, including mold design and manufacturability assessments.
  • Strong understanding of engineering design processes, DHF/DMR documentation, and design control requirements (especially for regulated industries).
  • Hands‑on experience with CAD tools (e.g., Creo, Solid Works, CATIA, or NX) and tolerance stack‑up analysis.
  • Familiarity with DFMEA, risk management, and verification/validation testing planning.
  • Knowledge of IP6X/UL/IEC standards and compliance requirements.
  • Proficiency in project management tools such as MS Project, and documentation tools such as MS Office (Word, Excel, PowerPoint).
  • Excellent skills in cross‑functional collaboration with hardware, firmware, and testing teams.
  • Strong organizational, communication, and stakeholder management abilities for offshore/onshore coordination.
  • Experience in supplier interaction, design reviews (DSR), and cost‑quality‑schedule optimization.
  • Ability to manage multiple projects simultaneously under tight deadlines.
Preferred
  • Experience as CAPA Owner for engineering non‑conformances.
  • Exposure to supplier quality management and direct/indirect sourcing.
  • Working knowledge of FEA, thermal, and fluidic simulations collaboration processes.

Mid‑Senior level – Full‑time – Project Management and Information Technology – Business Consulting and Services.

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