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Development engineer • chicago il

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Medical Device Development

NYTPChicago, IL, Illinois, USA
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Staff Software Development Engineer

WEX IncChicago, IL
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Development Associate

North Lawndale College Prep Charter High SchoolChicago, IL, USA
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Reports To: Director of Advancement.The Development Associate is a critical, frontline fundraising position responsible for executing key strategies across all fundraising channels, with a primary ...[internal_linking.show_more]

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Exit FactorChicago, Illinois, United States
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Rise25Chicago, IL, US
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EmployBridgeChicago, IL 60601, USA
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Clearwater AnalyticsChicago,
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Business Development Representative

RLDatixChicago, IL, US
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Business Development Representative | Sales | North America | Hybrid or Remote.RLDatix (RLD) is on a mission to help raise the standard of care…everywhere.Trusted by over 10,000 healthcare organiza...[internal_linking.show_more]

Learning & Development Specialist – Leadership Development | Remote

wholeheartedlifestyleChicago, Illinois, United States
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[job_card.full_time]

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VP, Account Development

NielsenIQChicago, Illinois, United States
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Civil Engineer – Land Development (Civil 3D)

LuxusChicago, IL, United States
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Civil Engineer – Land Development (Civil 3D) | 3–8 Years.Overland Park, KS • Chicago, IL • Schaumburg, IL • Davenport, IA.Commercial, Education, Municipal/Public, Infrastructure Site Development.St...[internal_linking.show_more]

Development Manager

Path ConstructionChicago, IL, US
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Development Manager to lead the execution of the company’s development and new construction strategy, identifying and managing projects across Illinois, Tennessee, North Carolina, and Arizona.Path ...[internal_linking.show_more]

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Benesch LawChicago, IL, United States
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Civil Engineer - Land Development

StantecChicago, IL
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Strong communities don’t just happen.They’re thoughtfully planned and future-ready.We bring life to urban downtowns, suburban hubs, small towns, and rural areas through master-planned communities, ...[internal_linking.show_more]

Business Development Representative

Pearl Consulting GroupChicago, IL, US
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Business Development Representative (BDR) Pearl Consulting Group - Chicago, IL Pearl Consulting Group (PCG) is a cybersecurity and transformation consultancy that specializes in Project Management,...[internal_linking.show_more]

Civil Engineer - Land Development/Design

GpacChicago, Illinois, United States
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A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer.We work hard to ensure that our projects are planned, designed & managed to meet not o...[internal_linking.show_more]

Project Development Sales Engineer - Microgrid Controls

Schneider ElectricChicago, US
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The compensation range for this full-time position applies to candidates located within the United States.Our salary ranges are determined by reviewing roles of similar responsibility and level.Wit...[internal_linking.show_more]

Business Development Representative

CoinFlipChicago, IL, United States
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Business/Sales Development Representative.CoinFlip is a global digital currency platform company focused on providing consumers with simple and secure access to buy and sell cryptocurrency.The comp...[internal_linking.show_more]

Analyst, Corporate Development

CresaChicago, IL, US
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At Cresa, we believe our clients deserve better.A better space to work, create, build, grow.A better outcome for their people and organization.A better partner who puts their needs first, helping t...[internal_linking.show_more]

Medical Device Development

Medical Device Development

NYTPChicago, IL, Illinois, USA
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  • [job_card.full_time]
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Job Summary

We are seeking an experienced Senior Engineer - Medical Device Development with strong hands-on expertise across the end‑to‑end medical device product development lifecycle, including design, documentation, verification & validation (V&V), and regulatory compliance.

The ideal candidate will have deep experience working in regulated medical device environments and hands-on proficiency with QMS, PLM, requirements, and CAD tools such as MasterControl, Arena, Jama, and SolidWorks, in alignment with FDA, ISO 13485, and applicable IEC standards.

Required Qualifications

Education

  • Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.

Experience

  • 5-10 years of hands-on experience in medical device development.
  • Proven experience working in regulated (GxP) environments.
  • Direct, hands-on experience with :
  • MasterControl
  • Arena PLM
  • Jama
  • SolidWorks
  • Experience with design controls and risk management (ISO 14971).

Technical Skills

  • Strong understanding of :
  • Design Controls & DHF management
  • Requirements traceability
  • Verification & Validation (V&V)
  • Change control and configuration management
  • Familiarity with tools such as Altium, Windchill, Teamcenter, Minitab, IBM DOORS, or Veeva Vault is a plus.

Soft Skills & Competencies

  • Strong analytical and problem-solving skills
  • Excellent documentation and technical writing abilities
  • Ability to work independently and in cross-functional teams
  • Strong communication skills with stakeholders and leadership
  • High attention to detail with a compliance-focused mindset

Key Responsibilities

Product Development & Engineering

  • Lead and contribute to medical device design and development activities from concept through commercialization.
  • Develop, review, and maintain design inputs, outputs, specifications, and technical documentation aligned with user needs and regulatory requirements.
  • Perform CAD modeling, design updates, and engineering drawings using SolidWorks or equivalent mechanical CAD tools.
  • Support design verification, validation, and risk management activities throughout the product lifecycle.

Quality & Regulatory Compliance

  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards.
  • Author, review, and maintain Design History File (DHF), Device Master Record (DMR), and related technical documentation.
  • Support internal and external audits, regulatory inspections, and submission readiness activities.
  • Participate in change management, deviation investigations, and CAPA processes.

Tools & Systems (Hands-On)

  • Actively use and manage documentation and records within :
  • MasterControl - QMS, document control, training, change management
  • Arena PLM - BOMs, ECOs, configuration, and product lifecycle management
  • Jama - requirements management and traceability matrices
  • SolidWorks - mechanical design and engineering drawings
  • Ensure end‑to‑end traceability across requirements, design, risk, and test artifacts.

Cross-Functional Collaboration

  • Work closely with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams.
  • Collaborate with suppliers and manufacturing partners to support DFM / DFA and production transfer.
  • Support technology transfer, scale‑up, and manufacturing readiness activities.