- Abbott (Sylmar, CA)
- …combination of education and work experience. + Minimum 7 years of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ... or irregular heartbeats. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality … more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …communication and data handling. + Regulatory Compliance: Design software with FDA , QSR, and ISO quality system regulations in mind, ensuring adherence ... with structured software development methodologies (Agile, Scrum) and maintaining software quality within a regulated environment. + Technical Leadership:… more
- Abbott (Sylmar, CA)
- …Our location in **Sylmar, CA** , currently has an opportunity for a ** Software Quality Engineer II** **.** This position is responsible for executing ... integrity risks. + Follow approved Design Control procedures for software development in accordance with FDA guidelines....education and work experience + Minimum 2 years + Software Quality Engineering experience + Prior medical… more
- Abbott (Burlington, MA)
- …health and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance ... oversight for Software Development projects. The **_Staff Software Quality Engineer_** is responsible for executing...FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… more
- Abbott (Alameda, CA)
- …+ 5 to 8 years' experience in Software Quality Assurance and/or Software Testing experience. + Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR ... + Participate as a lead member of the Non-Product Software Quality Assurance (SWQA) team for Abbott...of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... understanding of medical device software standards such as IEC 62304. ** Software Quality Engineering Expertise:** 1. Hands-on experience in Software … more
- Stryker (San Jose, CA)
- **Stryker** is hiring a **Staff Software Quality Engineer, Post Market** to support our Medical's Digital Health division and portfolio Software as a Medical ... Partner with the Professional Services and Technical Support Organization to ensure quality customer outcomes through software solution installation and tech… more
- Stryker (Portage, MI)
- **Stryker** is hiring a **Staff Software Quality Engineer, Design Assurance** to support our Medical's Digital Health division and portfolio Software as a ... (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market...improvement across the software lifecycle by implementing software industry best practices and regulatory standards ( FDA… more
- Fresenius Medical Center (Lawrence, MA)
- …Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation or ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...experience in software engineering, information technology, or software quality assurance in a regulated environment;… more
- Abbott (Atlanta, GA)
- …Qualifications** + BS in Engineering or Technical Field + 2 years Software Quality Engineering experience **Preferred Qualifications** + Detailed knowledge of ... for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division. **What… more
- Medtronic (Jacksonville, FL)
- …an excellent opportunity to join the ENT Quality team as a Senior Software Quality Engineer. This position is based onsite in Jacksonville, FL. In this ... verification and validation. + Defines appropriate measures to ensure software quality . Develops and maintains quality...policies and Standard Operating Procedures (SOPs) to ensure that FDA , ISO and European Medical Device quality … more
- Wolters Kluwer (Chicago, IL)
- …compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities focused on 21 CFR 820, ISO ... testing activities, including verification and validation. + Lead resolution of quality issues with on-market device software ; drive investigations related… more
- Abbott (Alameda, CA)
- …embedded software development and project scheduling. + Reliably deliver high- quality software with-in schedule constraints. + Provides technical ownership ... development, verification, and validation; responsible for on-time delivery of high- quality embedded software biowearable products that meet budgetary… more
- Medtronic (Mounds View, MN)
- …internal and external audits (eg, FDA , Notified Body, MDSAP), ensuring software quality documentation and evidence meet regulatory expectations. + **Training ... connected, compassionate world. **A Day in the Life** Senior Software Quality Engineer Careers that Change Lives...compliance with global medical device regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, ISO… more
- Abbott (Pleasanton, CA)
- …experience managing a team of technical/ quality professionals. + Knowledge of FDA regulations and guidance, ISO 13485, Software Standards (eg, IEC 62304), ... their health and get on with their lives. As a Senior Manager focusing on Software Quality and associated design controls at Heart Failure, you will have the… more
- Medtronic (Boston, MA)
- …the software verification lifecycle, ensuring efficient and effective delivery of high- quality software . + Drive the adoption and continuous improvement of ... quality management system procedures. + Collaborate cross-functionally with software development, systems engineering, quality assurance, and regulatory… more
- Cedars-Sinai (Los Angeles, CA)
- …years of experience using 3D model software preferred + Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO ... and full end-to-end integration tests, when it applies; Supports quality insurance effort to gain user acceptance. 4. Delivery:...standards. + Ability to use structural finite element analysis software such as Cosmos or Ansys. + Demonstrate data… more
- PDS Tech Commercial, Inc. (Irvine, CA)
- **Shape the Future of Medical Innovation - Join Us as a Software Engineer III (Embedded Systems)!** _Hybrid | Irvine, CA | $78.78/hour | Monday - Friday, 8:00 AM - ... It Matters Most** PDS Tech Commercial is seeking a ** Software Engineer III (Embedded Systems)** to support our client...devices. + Align firmware development with **IEC 62304** , ** FDA ** , and **ISO** standards. + Identify and mitigate… more
- Actalent (Auburndale, MA)
- …testing, defect tracking, and collaboration with cross-functional teams to deliver high- quality software . Responsibilities + Conduct thorough manual testing of ... quality assurance, to ensure the delivery of high- quality software . + Participate in continuous improvement...Understanding of regulatory requirements and standards for medical device software (eg, FDA , ISO). + Strong analytical… more
- Abbott (Atlanta, GA)
- …knowledge of FDA and international regulatory requirements for medical device software + Knowledge within the medical device industry including IEC 62304 ... telemedicine etc.). We are recruiting for a **Staff Embedded Software Engineer** to join our Abbott Heart Failure team...heart failure, lower heart failure mortality rates, and improve quality of life for our heart failure patients. The… more