ISO 13485 jobs in Delaware

Loftware Spectrum Technical Lead / Solution Engineer

Remote

•

10d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

Easy Apply

Contract

Depends on Experience

Technical Project/Program Management - Technical Program Manager V

Remote

•

Today

Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V Compensation: $12- - $130 hourly Location: Remote, California (Remote) Role Overview We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance wit

Easy Apply

Full-time

$120 - $130 per hour

GRC Analyst

Remote

•

3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

Easy Apply

Contract

$60 - $70

Senior Manager IT Manufacturing Applications

Remote or San Diego, California

•

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 141,800.00 - 236,400.00 per year

Principal National Support Engineer II

Remote

•

Today

Position Overview The Principal National Support Engineer II provides the highest level of technical expertise and experience to the Fujifilm Healthcare Medical Informatics business covering all currently offered products including, but not limited to: storage systems, PACS (Radiology/Cardiology), VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems. While this position primarily supports the Technical Assistance Center (TAC), technical leadership and direction is provided to all

Full-time

USD 110,366.00 - 130,909.00 per year

Sr CAPA Engineer

Remote or Waltham, Massachusetts

•

Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Sr. Engineer, Product Cyber Security

Remote or Ashland, Oregon

•

Today

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biol

Full-time

USD 117,800.00 - 188,600.00 per year

CAPA Facilitator, Engineer

Newark, Delaware

•

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

Oracle DBA (National Support Engineer role for Medical Imaging)

Remote

•

Today

Position Overview The Distinguished National Support Engineer provides the highest level of technical expertise and experience to the Fujifilm Healthcare Medical Informatics business covering all currently offered products including, but not limited to: storage systems, PACS (Radiology/Cardiology), VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems. While this position may provide direct support to the Technical Assistance Center (TAC), the primary focus is technical leadership

Full-time

USD 110,366.00 - 146,364.00 per year

Sr. Product Quality Engineer

Newark, Delaware

•

Today

Job Description Join Hologic, a global leader in women's health, dedicated to developing innovative medical technologies that help detect, diagnose, and treat disease with greater accuracy and confidence. Headquartered in Newark, DE. Hologic's solutions impact millions of women worldwide across breast health, gynecologic health, and diagnostics. As part of our team, you'll contribute to products that improve patient outcomes and advance the standard of care, helping fulfill our mission of enabl

Full-time

USD 98,000.00 - 135,100.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

Remote or Plano, Texas

•

Today

Full-time

Product Quality Engineer 1

Newark, Delaware

•

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

Product Quality Engineer 2

Newark, Delaware

•

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. Lead cross functional team in implementation of improvements or corrections based on the results of complaint investigations. Essential Duties and Responsibilities Provide input in prioritization of complaints and investigation

Full-time

USD 78,000.00 - 122,100.00 per year

Systems Engineer 4

Newark, Delaware

•

Today

Job Description Job Summary: The Lead Systems Engineer provides systems engineering leadership across hardware, software, mechanical, electrical, clinical, manufacturing, quality, and regulatory functions to ensure successful development and commercialization of safe, effective, and compliant products. They may serve as the technical leader responsible for the definition, architecture, integration, and lifecycle management of complex medical device systems. The individual drives requirement de

Full-time

USD 119,300.00 - 186,600.00 per year

Imaging Service Engineer I - Minnesota

Remote

•

Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

•

Today

Job Description Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in

Full-time

USD 96,441.00 - 126,000.00 per year

Senior Product Quality Assurance Engineer (I&G)

Remote

•

Today

The Senior Design Quality Engineer ensures that new and existing digital health products from Incubation & Growth (I&G) areas comply with quality, safety, regulatory standards, and user requirements. He/She is specialized in design controls, overseeing verification and validation activities in alignment with internal quality management systems and external regulations. He/She should understand emerging technologies as part of I&G and supports the strategy from concept to commercial launch. What

Full-time

USD 122,000.00 - 184,000.00 per year

Principal Cybersecurity Assurance Engineer (Remote - United States)

Remote or Texas

•

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

Product Quality Engineer 3

Newark, Delaware

•

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

PLM Windchill Solution Architect/ SME

Remote

•

Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

Easy Apply

Third Party, Contract

Depends on Experience

ISO 13485 jobs in Delaware, USA