- 6+ years of Medical devices – Design / Development Quality experience on the projects related to Design Change, Clinical and New Product Development. New Product Development experience is a must.
- Experience working on implantable Class III medical devices or safety critical embedded systems is a must.
- Experience with software development life cycle (IEC 62304), verification/validation practices, and risk-based quality engineering.
- Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations
- Experience in compiling Design history files & Technical file submission for 510k & CE mark
- Own Risk Management files and ensure adherence to ISO 14971 – Risk management plan, Hazard Analysis, SFMEA, DFMEA, UFMEA, Risk Management report, etc.
- Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.
- Review & approve all the design history files with cross functional teams (including software deliverables)
- Support product development equipment qualification activities, inspection / test method development and validation activities.
- Strong in Medical devices technical documentation
- Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
- Strong analytical/problem solving, critical thinking, and presentation skills.
- Working knowledge of cybersecurity requirements, software configuration management, and requirements management tools (e.g., Polarion, Doors, Jira) would be preferred.
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+6 years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development. Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations. Experience in compiling Design history files · Work with c ...
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6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development. · Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations · ...
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Title: Design Quality Engineer · Location: Plano, TX (onsite) · Duration : Contract · Jd · 6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development. · Good experience in Medical devices regulations – ...
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Design quality engineer for medical devices projects. Experience in design change clinical new product development. · 6+ years of medical devices - design quality experience. · FDA EU MDR regulations and technical documentation skills. · ...
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Title: Design Quality Engineer · Location: Plano, TX (only onsite, no remote) · Long Term Contract Role · JD (Updated): · 6+ years of Medical devices – Design / Development Quality experience on the projects related to Design Change, Clinical and New Product Development. New Prod ...
Plano $90,000 - $155,000 (USD) per year2 days ago
Design Quality Engineer - Plano - Excelon Solutions
Description
Title: Design Quality Engineer
Location: Plano, TX (only onsite, no remote)
Long Term Contract Role
JD (Updated):
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Quality Engineer
Only for registered members Plano, TX
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Quality Engineer
Only for registered members Plano
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Quality Engineer
Only for registered members Plano
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Quality Engineering Lead
Only for registered members Plano
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Quality Assurance Engineer
Bluebix Solutions- Plano
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Design Quality Engineer
Only for registered members Plano
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Quality Engineering Lead
Only for registered members Plano, TX
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Quality Engineering Manager
Only for registered members Plano
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Quality Engineer I
Only for registered members Plano
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Mgr Quality Engineering
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano
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Quality Engineering Lead
Only for registered members Plano
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Software Engineer Quality
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano
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Quality Assurance Engineer
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano
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Design Quality Engineer
Only for registered members Plano