ISO 13485 jobs in Newark, DE

Newark, Delaware

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Today

Job Description Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner closely with Quality Management System, QMS, leadership and cross-functional teams to improve CAPA performance, support remediation efforts, build CAPA competency, and help sustain effective quality systems. The ideal candidate brings strong experience in quality assurance within a r

Full-time

USD 97,600.00 - 152,700.00 per year

Manager, Engineering

Newark, Delaware

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Today

Job Description Why Hologic: Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping ;healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. What to expect: The Manager of Manufacturing Engineering leads a team of engineers and technicians responsible for developing, improving, and supporting manufacturing processes, equipment, and tools. This role ensures tha

Full-time

USD 122,000.00 - 200,000.00 per year

Product Quality Engineer 3

Newark, Delaware

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Today

Job Description Hologic is a global medical technology company focused on women's health and wellbeing. Our Newark, Delaware team manufactures the 3Dimensions Mammography System, recognized as the "Coolest Thing Made in Delaware," which helps detect breast cancer earlier and with greater certainty. Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellen

Full-time

USD 85,300.00 - 133,000.00 per year

Product Quality Engineer 2

Newark, Delaware

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Today

Job Description Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you'll drive process improvements, assess risks, and de

Full-time

USD 78,000.00 - 122,100.00 per year

Product Quality Engineer 1

Newark, Delaware

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Today

Job Description Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field. Works with cross functional team in implementation of improvements or corrections based on the results of complaint investigations. Essential Duties and Responsibilities Own Investigations and associated root cause analysis, in

Full-time

USD 54,900.00 - 86,000.00 per year

Senior Software Design Assurance Engineer

Newark, Delaware

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Today

Job Description The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices. Kn

Full-time

USD 97,600.00 - 152,700.00 per year

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

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

Principal Cybersecurity Assurance Engineer (Remote - United States)

Remote or Texas

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Today

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant mat

Full-time

USD 124,000.00 - 170,500.00 per year

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

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 Test Method Validation (TMV) Subject Matter Expert (SME) / Lead

Delaware City, Delaware

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14d ago

Less of a LEAD and MORE of an SME Hands On Senior Level Subject Matter Expert ONSITE Title: TMV Engineer SME Daily duties of the contractor: TMV Engineer/specialist Key Requirement and experience: Develop and validate test methods for complex electromechanical medical device systems to verify essential clinical and system performance requirements. Demonstrate expertise in converting design and clinical requirements into repeatable, reproducible, and validation-ready test methods, including de

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Contract

$50 - $55

Senior Embedded Firmware Engineer

Newark, Delaware

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14d ago

Hi Associate, Greetings for the day, We have a position as a Senior Embedded Firmware Engineer role in Newark, DE. Please find the job description below for this position. Role: Senior Embedded Firmware EngineerLocation: Newark, DEDuration: Long Term Job Description:Bachelor s or master s degree in electrical engineering, Computer Engineering, or a related field.Senior-level commercial experience in embedded firmware development.Proven experience in regulated industries (e.g., Medical Devices /

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Contract

Depends on Experience

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

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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 Newark, DE, USA