![Barrington James](https://media.trabajo.org/img/noimg.jpg)
Senior Design Quality Engineer
7 days ago
Senior Design Quality Engineer - (Medical Device) - Hybrid in Chicago, IL
Our client is at the forefront of medical device innovation, committed to enhancing patient outcomes with cutting-edge technology and innovative design. They have dedication to quality and are looking for a Senior Design Quality Engineer to join their growing team.
As Senior Design Quality Engineer you will be working 2 days a week onsite in Chicago. In this role, you will ensure the quality and compliance of medical device designs throughout the product development lifecycle. This position requires a deep understanding of design controls, risk management, and regulatory requirements.
Key Responsibilities:
- Lead design quality activities for new product development and sustaining engineering projects.
- Develop and implement design control procedures in line with FDA, ISO 13485, and other regulatory requirements.
- Conduct design reviews, risk assessments, and failure mode effects analysis (FMEA) to ensure product safety and efficacy.
- Collaborate with R&D, manufacturing, regulatory, and marketing teams to meet design quality objectives.
- Review and approve design verification and validation plans, protocols, and reports.
- Support regulatory submissions with necessary design quality documentation and evidence.
- Monitor and analyze design-related quality metrics, driving continuous improvement initiatives.
- Manage all parts of the Quality System - CAPA, Design Controls, Document Controls, Complaints, pFMEA, dFMEA, and uFMEA.
- Stay current with industry trends, standards, and regulations to ensure compliance and innovation.
Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical) or relevant field; advanced degree preferred.
- 7-10 years of experience in design quality engineering within the medical device industry.
- Strong knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 60601, and 21 CFR Part 820.
- Proven experience with design controls, risk management, and product development processes.
- Excellent analytical and problem-solving skills, with keen attention to detail.
- Strong communication and interpersonal skills, with the ability to work effectively in a team.
- Certification in quality engineering (e.g., CQE, Six Sigma) is a plus.
- Proficiency in quality management software and tools.
If you would like to learn more about this Senior Design Quality Engineer then apply today or reach out to me:
wjlynch@barringtonjames.com
-
Senior Quality Engineer Architect
7 days ago
Chicago, United States Wolters Kluwer N.V. Full timeThe Senior Quality Engineer Architect functions as a technical leader, playing a central role in defining and establishing technical and strategic direction for the - /dxg Engineering organization. Working with agile teams to plan, design, and implem Quality Engineer, Architect, Engineer, Quality Assurance, Senior, Quality
-
Senior Electrical Design Engineer
4 weeks ago
Chicago, United States Ardmore Roderick Full timeArdmore Roderick is a full-service civil engineering firm providing infrastructure design, construction services and program management to a variety of agencies.Headquartered in Chicago, we have offices in Champaign, IL, Orlando, FL, and Philadelphia, PA. Ardmore Roderick was recently named by Crain's Chicago as one of the fastest growing companies in the...
-
Senior Electrical Design Engineer
3 weeks ago
Chicago, United States Ardmore Roderick Full timeArdmore Roderick is a full-service civil engineering firm providing infrastructure design, construction services and program management to a variety of agencies.?Headquartered in Chicago, we have offices in Champaign, IL, Orlando, FL, and Philadelphia, PA. Ardmore Roderick was recently named by Crains Chicago as one of the fastest growing companies in the...
-
Senior Electrical Design Engineer
4 weeks ago
Chicago, United States Ardmore Roderick Full timeArdmore Roderick is a full-service civil engineering firm providing infrastructure design, construction services and program management to a variety of agencies.Headquartered in Chicago, we have offices in Champaign, IL, Orlando, FL, and Philadelphia, PA. Ardmore Roderick was recently named by Crain's Chicago as one of the fastest growing companies in the...
-
Senior Electrical Engineer
1 month ago
Chicago, United States Managed Staffing Full timeNeed 2 Strong Resume Title: Senior Electrical Engineer / Designer Location: Chicago, IL Job type: Fulltime Salary: $115K - $150K Note: We strongly prefer candidates with Chicago-specific experience (whether or not they’re currently in Chicago), but at this point will consider candidates without Chicago-specific experience. Client is seeking experienced and...
-
Senior Mechanical Design Engineer
1 month ago
Chicago, United States SEGULA Technologies Full timeCompany Description MUST be authorized to work in the United States for any employer. Unable to consider CPT or OPT candidates. SEGULA TECHNOLOGIES is assisting our client in hiring a Senior Mechanical Design Engineer, Chassis to join their growing team in in the West / Southwest region of the United States. Our client is an automotive / transportation...
-
Senior Transmission Line Design Engineer
2 weeks ago
Chicago, United States Infra-Rec Full timeJob Title: Senior Transmission Line Design Engineer Location: Chicago, IL. Overview: As a Senior Transmission Line Design Engineer, you will lead the design, analysis, and optimization of high-voltage transmission lines, ensuring the reliability, efficiency, and safety of electrical power delivery systems. This role requires extensive experience in...
-
Senior Electrical Engineer
1 month ago
Chicago, United States Allen + Shariff Corporation Full timeJob DescriptionJob DescriptionAllen + Shariff is an international MEP engineering firm providing consulting and design services from five locations in the United States and project management services in the Middle East. Our mission is to engineer an exceptional level of personal care and connection designed to help our clients, employees, and communities...
-
Senior Civil Design Engineer
1 month ago
Chicago, United States Northern Impact Full timeOverview National Award-Winning Engineering Firm is seeking a highly motivated Senior Civil Design Engineer. This position requires you to work with a growing civil engineering group on a diverse variety of projects. Project work currently includes civil site development for new and redevelopment sites, grading design, stormwater management (hydraulic and...
-
Senior Civil Design Engineer
2 weeks ago
Chicago, United States Northern Impact Full timeOverview National Award-Winning Engineering Firm is seeking a highly motivated Senior Civil Design Engineer. This position requires you to work with a growing civil engineering group on a diverse variety of projects. Project work currently includes civil site development for new and redevelopment sites, grading design, stormwater management (hydraulic and...
-
Senior Software Quality Engineer
1 month ago
Chicago, United States Tempus Full timePassionate about precision medicine and advancing the healthcare industry?We are looking for a Senior Software Quality Engineer (Software Design Controls) who will be involved in the software quality management system (QMS) and software development life cycle (SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, CAP/CLIA,...
-
Senior Software Quality Engineer
1 month ago
Chicago, United States Tempus Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Senior Quality Engineer
4 weeks ago
Chicago, United States GE Healthcare Full timeJob Description Summary As a Senior Quality Engineer, you will provide quality engineering process support to GE HealthCare digital products in accordance with GE HealthCare medical device Quality Management System (QMS). You will be responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance...
-
Senior Software Quality Test Engineer
3 weeks ago
Chicago, United States GE Healthcare Full timeJob Description Summary As a Senior Software Quality Test Engineer, you will be responsible for designing, developing, automating and executing test plans and test cases to ensure quality and reliability of GEHC products. You will collaborate closely with developers to design test cases, cross-functionally with Quality, Regulatory, program management to...
-
Senior Designer
1 month ago
Chicago, United States Drury Design Full timeJob DescriptionJob DescriptionJob Title: Senior Designer - Kitchen/Bath Design Firm Location: 512 Main Street, Glen Ellyn, IL 60137Position Type: Full-Time If you are a talented designer with formidable experience, a passion for creating exceptional kitchen and bath spaces, and you thrive in a role that combines design, project management, and sales, we...
-
Senior Quality Engineer
1 month ago
Chicago, United States GE Healthcare Full timeJob Description Summary As a Senior Quality Engineer, you will provide quality engineering process support to GE HealthCare digital products in accordance with GE HealthCare medical device Quality Management System (QMS). You will be responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance...
-
Senior Software Quality Engineer
1 month ago
Chicago, Illinois, United States Vivid Seats Full timeWho we are: Founded in 2001, Vivid Seats (NASDAQ: SEAT) is a leading online ticket marketplace committed to becoming the ultimate partner for connecting fans to the live events, artists, and teams they love. We believe in the power of experiences and are fiercely dedicated to building products that inspire human connections. Named as one of Built In's top...
-
Senior Software Quality Engineer
1 month ago
Chicago, United States Vivid Seats Full timeWho we are: Founded in 2001, Vivid Seats (NASDAQ: SEAT) is a leading online ticket marketplace committed to becoming the ultimate partner for connecting fans to the live events, artists, and teams they love. We believe in the power of experiences and are fiercely dedicated to building products that inspire human connections. Named as one of Built In's top...
-
Project Designer
3 weeks ago
Chicago, United States Design Environments Full timeJoin Our Team as a **Project Designer** **About Us**:At** Design Environments**, we have a higher goal than simply delivering a beautiful space. We are focused on creating memorable and experiential interior environments for every project while improving the world we live in. We are a team of diverse experts with more than 40 years of experience in a...
-
Senior Technology Engineering Designer
3 weeks ago
Chicago, United States CannonDesign Full timeCannonDesign has an exciting opportunity for a Senior Technology Engineering Designer based in our Chicago, IL office. Take a look at the description below. If you think your skills and experience make you a good match for this position, we'd love to hear from you. We're looking for creative, curious, empathetic people to join our Living-Centered Design...