Ecocareers · 20 hours ago
Senior Design Quality Engineer
Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expConfidential company is looking for a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products. This role involves collaborating with R&D, Manufacturing, and Regulatory teams to ensure compliance with medical device quality and regulatory requirements, focusing on design controls, verification & validation, and product lifecycle quality support.
Staffing & Recruiting
Responsibilities
Support quality activities across the product lifecycle for electromechanical and combination medical devices
Apply Design Controls (21 CFR 820.30 / ISO 13485) during product development
Review and approve design inputs/outputs, test protocols, and validation reports
Support design verification and validation testing for mechanical, electrical, and software-controlled systems
Participate in risk management activities (FMEA, hazard analysis, risk reviews)
Ensure traceability from user needs → requirements → verification → validation
Support change control and engineering change assessments
Investigate quality issues and support root cause analysis and CAPA
Review DHF/DMR documentation for completeness and compliance
Partner with engineering and manufacturing teams to ensure quality is built into product design
Support supplier quality activities for critical components
Contribute to regulatory submission documentation as needed
Qualification
Required
Bachelor's and Master's degree in Mechanical, Electrical, Biomedical, or related Engineering field
8+ years Quality Engineering or Quality Assurance experience in medical devices
Hands-on experience with electromechanical medical devices
Strong working knowledge of Design Controls
Risk Management (ISO 14971)
ISO 13485 / FDA 21 CFR 820
Experience supporting verification & validation testing
Experience with DHF documentation and change control
Experience performing investigations and CAPA
Ability to work cross-functionally with engineering teams
Preferred
Experience with infusion pumps or drug delivery systems
Combination product experience
Knowledge of IEC 60601, IEC 62304, or IEC 62366
Experience supporting 510(k) or other regulatory submissions
ASQ CQE / CQA certification
Experience with eQMS systems
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase