Iso 13485 jobs in dallas, tx

Dallas, Texas

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Today

Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment. Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits. Establish preventive maintenance plans, calibration schedules, and critical spare parts lists. Author validation plans, validation protocols, test reports, inc

Full-time

SMT Sr Engineer - Process

Dallas, Texas

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Today

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. The Senior SMT Process Engineer (SME) is a critical member of Creation's Customer Focused Team, responsible for bringing our customer's new product designs into realization. The technical experience and expertise will be an asset to regional or companywide initiatives. The SME will ensure our products always meet customer requirements and speci

Full-time

Staff Software Quality Engineer, Post Market Integration

Flower Mound, Texas

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Today

Work Flexibility: Hybrid or Onsite Stryker is hiring a Staff Software Quality Engineer, Post Market Integration endoscopy and communications business. In this highly visible role, you will serve as a quality engineering leader for commercialized products, driving complex investigations, risk management activities, product quality improvements, and regulatory compliance across the product lifecycle. Partnering closely with R&D, Operations, Commercial, and Quality teams, you will lead customer co

Full-time

USD 112,900.00 - 188,100.00 per year

SMT Process Engineer (1st Shift)

Carrollton, Texas

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Today

Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, c

Full-time

Validation Engineer

Dallas, Texas

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Today

Validation Engineer Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world. Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions to solve our customers' most complex challenges. Position Title: Validation Engineer FLSA: Salary Exe

Full-time

Software Engineer

Dallas, Texas

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Today

Position Summary: Spectral AI, Inc. (Spectral) is seeking a software engineer to join our growing design and development team. The position is based in Dallas, Texas, with hybrid work flexibility in accordance with the Spectral Employee Handbook guidelines. This position will assist in the integration of computer vision algorithms into our Windows-based DeepView AI software. This role focuses on bridging advanced GPU-based reconstruction and segmentation algorithms with a clinical production sof

Full-time

Auditor

Remote or Chicago, Illinois

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Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Principal AI Solutions Architect, Healthcare & Life Sciences - US

Dallas, Texas

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Today

Position overview As a Principal AI Solutions Architect within DataArt's Healthcare & Life Sciences practice, you will bridge the gap between advanced AI tools and real-world business impact. You'll operate at the intersection of hands-on prototyping, cross-functional collaboration, and stakeholder education. Your focus: drive measurable client outcomes through AI-enabled efficiencies and new digital experiences. You will shape how AI is adopted across the healthcare and life sciences industries

Full-time

USD 190,000.00 - 240,000.00 per year

Backend AI Engineer - Remote

Remote or San Diego, California

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Today

Genesis10 is currently seeking a Backend AI Engineer - Remote for a contract position with a Global Medical Technology Company located in San Diego, CA. This is a 12+ month contract opportunity. This position is 100% remote. Compensation: $43.00 - $53.00 per hour, W2, based on qualifications Position Overview: This role focuses on developing and implementing generative AI solutions, including building robust RAG pipelines, fine-tuning LLMs, and creating high-performance APIs. The ideal candidat

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Full-time

Compensation information provided in the description

Senior Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Technical Analyst, Operations Quality

Richardson, Texas

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Today

Req ID: 136070 Region: Americas Country: USA State/Province: Texas City: Richardson General Overview Functional Area: Quality (QUA) Career Stream: Operations Quality (OPQ) Role: Technical Analyst (TAN) Job Title: Technical Analyst, Operations Quality Job Code: TAN-QUA-OPQ Job Level: Band 07 Direct/Indirect Indicator: Indirect Summary Provides support in the performance and daily activities of the department Analyzes quality data and prepares reports for internal teams and extern

Full-time

Staff Software Engineer

Remote or California

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Today

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team me

Full-time

USD 140,000.00 - 160,000.00 per year

Senior Account Manager- Medical Devices

Remote

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Today

Req ID: 137305 Remote Position: Yes Region: Americas Country: USA Summary Celestica is dedicated to delivering end-to-end product lifecycle solutions to drive our customers' success. Our growing Advanced Technology Solutions (ATS) organization focuses on applying Celestica's advanced capabilities, knowledgeable people and innovative tools to enable companies in the medical device industry with highly complex, mission critical applications to improve their competitive advantage. We are current

Full-time

USD 123,000.00 - 163,000.00 per year

Principal Engineer, Customer Quality

Remote

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Today

Littelfuse (NASDAQ: LFUS) is a diversified industrial technology manufacturing company shaping solutions for the safe and efficient transfer of electrical energy. Headquartered in Chicago, Illinois, USA, we serve customers across industrial, transportation, and electronics markets worldwide. With approximately 16,000 employees we design and manufacture innovative technologies that support electrification, energy efficiency, and advanced automation. Our global reach is matched by a culture that e

Full-time

USD 123,100.00 - 190,780.00 per year

Senior Database Design Engineer

Remote

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Today

Full-time

USD 100,000.00 - 120,000.00 per year

Principal HL7 Integration Engineer

Remote

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Today

Position Overview The Principal HL7 Integration Engineer oversees all technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. The Principal HL7 Integration Engineer must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in general and clinical environment workflow. In addition to technical expertise, HCUS relies on Th

Full-time

USD 110,366.00 - 140,000.00 per year

Senior Electrical Engineer

Allen, Texas

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Today

Job Summary As part of a $70M+ manufacturer of surgical solutions for the medical industry, the Senior Electrical Engineer is a senior-level technical leader responsible for both sustaining production and leading complex electrical and electromechanical projects. This role owns system-level electrical performance across manufacturing, test, field issues, and product changes. The position requires the ability to independently lead projects, mentor engineers and technicians, and resolve daily pro

Full-time

Medical Device V&V engineers

Remote or New Jersey

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Today

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Senior PLM Windchill Solution Architect

Remote

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4d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

Easy Apply

Contract

80 - 90

Senior Software Design Assurance (Sr Software Design Quality) Engineer

Remote

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 95,900.00 - 159,900.00 per year

Iso 13485 jobs in Dallas, TX, USA