- Zimmer Biomet (Austin, TX)
- …partners (internal and external) + You will support audit readiness and serve as the software quality SME during internal, FDA , and Notified Body audits + ... empowered and recognised. **What You Can Expect** As a ** Software Quality Manager** you will be responsible...Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity… more
- Caris Life Sciences (Irving, TX)
- …practices at Caris Life Sciences. This individual will work closely alongside Software Quality Leadership, engineering, and other cross-functional partners to ... and SaMD products are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA...regulation requirements. + Collaborates with regulatory partners as a software quality subject matter expert to support… more
- Abbott (Sylmar, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. **Job Title** ** Software Quality Engineer II** **Working at Abbott** At Abbott, you can ... **The Opportunity** Our location in **Sylmar, CA** currently has an opportunity for an ** Software Quality Engineer** . **This is a fully onsite role** . This… 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 Design Quality Engineer** to support our Medical's Digital Health division and portfolio Software as a Medical ... (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
- MetaOption, LLC (Sunnyvale, CA)
- …* Experience deploying and supporting medical device software under FDA regulations. * Familiarity with quality management systems, validation procedures, ... the production infrastructure supporting our regulated digital health and medical software platforms. You will ensure reliability, scalability, and compliance of… more
- Medtronic (Newton, MA)
- …the usage of Affera grows rapidly worldwide. **Primary Responsibilities** + Support software quality and reliability efforts for Cardiac Ablation Solutions ... products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. +...risk analysis and defect assessments. + Influence and analyze software quality metrics for assigned programs, ensuring… more
- Medtronic (Minneapolis, MN)
- … software - Part 1: General requirements for product safety + United States FDA Device Software Functions related Guidance's + United States FDA ... Guidance's + United States FDA AI-Enabled Device Software Function Guidance + European Commission's Guidance's on Medical...auditing Quality Systems to global requirements + Quality System Lead Auditor certified + Prior FDA… more
- Zimmer Biomet (Austin, TX)
- …included, respected, empowered and recognised. **What You Can Expect** As a **Senior Software Quality Engineer** you will be responsible for performing manual & ... clear and efficient test plans for complex systems involving multiple software components. + FDA or experience working directly in the Medical Device field,… more
- Abbott (San Diego, CA)
- …modeling and security architecture reviews** for embedded medical devices and supporting software . + Collaborate with engineering, quality , and regulatory teams ... diversity, working mothers, female executives, and scientists. **The Opportunity** This ( Software Development) Sr. Product Security Engineer role works **on site… 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
- Oracle (Augusta, ME)
- …record of mentoring and guiding engineers, fostering adoption of compliant and high- quality software engineering practices. Disclaimer: **Certain US customer or ... and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system… more
- Abbott (Milpitas, CA)
- …and implement process improvements. Collaborating with cross-functional teams, they ensure high- quality software delivery and contribute to the full development ... design control procedures. + Provide technical leadership and mentoring for embedded software projects. + Ensure high- quality software delivery within… more
- Abbott (Alameda, CA)
- …and implement process improvements. Collaborating with cross-functional teams, they ensure high- quality software delivery and contribute to the full development ... design control procedures. + Provide technical leadership and mentoring for embedded software projects. + Ensure high- quality software delivery within… more
- Bayer (Indianola, PA)
- …responsible to perform software development of medical devices to deliver a high- quality product that meets or exceeds customer expectations and meets FDA ... and diverse minds to make a real difference, there's only one choice.** ** Software Engineer I** ** Software Engineer - Indianola, PA** **PURPOSE** This position… more
- VTI Life Sciences (San Diego, CA)
- …in Engineering, Life Sciences, or related discipline. + 7+ years of relevant FDA -regulated industry experience in Software Validation. + Expertise in regulatory ... the Life Sciences industry. We are looking for a Software Validation Specialist to be responsible for ensuring that...in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity,… more
- Bayer (Indianola, PA)
- …and diverse minds to make a real difference, there's only one choice.** **Sr. Software Engineer (Full Stack)** **PURPOSE:** As a Senior Software Engineer, you ... the development of medical devices, ensuring the delivery of high- quality products that meet or exceed customer expectations and...that meet or exceed customer expectations and comply with FDA design controls. You will be involved in all… more
- Abbott (Burlington, MA)
- …Software Design Quality is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering ... contributor and provide guidance or oversee work of other Software Quality team members. + Support audits...FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… 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