- Merck & Co. (Rahway, NJ)
- …deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients.The successful ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …of regulatory activities with cross- product or cross-functional impact, including drug device /combination products and software as medical device ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Twist BioScience (South San Francisco, CA)
- … of workProficient with project management tools and applications (such as Smartsheets/Asana/JIRA/Confluence)Preferred Qualifications:Experience working in both ... team members through ISO 13485 design control process; creates and maintains a high- quality DHF.Builds high morale and team commitments to goals and objectives by… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …Staff Quality Assurance Engineer or Scientist is responsible for facilitating application of quality system and design control processes with teams across ... and product improvement projects for Beckman Coulter Life Science.Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes… more
- Cytiva (Miami, FL)
- …life-changing career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer will be the subject matter expert for the ... ownership of the Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is part of the Quality Assurance Department… more
- Actalent (Minneapolis, MN)
- Job Title: Software Quality EngineerJob Description We are seeking a detail-oriented Software Quality Engineer who is adept at coaching staff and ... PHI and PII compliantly. Essential Skills + Proficiency in software quality assurance, validation, and software...Workplace Type This is a hybrid position in Minneapolis,MN. Application Deadline This position is anticipated to close on… more
- Abbott (Alameda, CA)
- …validation, and maintenance of application in support of medical device software . + Software Quality lead in various phases of the development ... following: + Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott...the development, verification, validation, use, and maintenance of medical device software . + Coordinate activities with other… more
- SpaceX (Woodinville, WA)
- …the Starlink constellation. You will work with large-scale data pipelines as well as device software to drive quality observability across the program. Your ... findings may drive improvements to the Starlink device software , constellation software , or satellite software Our software engineers are responsible… more
- Edwards Lifesciences (Naperville, IL)
- …Experience in medical device industry, preferably with electromechanical devices and medical device software * ASQ Certified Quality Engineer * Technical ... experience creating SOPs in a Quality Management System * Experience with quality principles and tools * Capability in application of statistical techniques… more
- Wolters Kluwer (Chicago, IL)
- …system testing activities, including verification and validation. + Lead resolution of quality issues with on-market device software ; drive investigations ... product nonconformities and implement CAPA plans. + Serve as Quality approver for device software ... system requirements. + Experience compiling and submitting regulatory applications and submissions + Familiarity with SaMD is preferred.… more
- Philips (Cambridge, MA)
- **R&D Application Software Engineer - C++ & Python for Medical Device (Cambridge, MA)** Join the Breakthrough Innovation Teams (BRITE) at Philips to build ... scale. **Your role:** + Design, develop, deploy, and release software applications in an FDA-regulated environment for...in C++ and Python are required). Experience in medical device is required. + You have knowledge in medical… more
- Amazon (El Segundo, CA)
- …multidisciplinary team developing targeted and scalable solutions for custom satellite and ground applications . KGS Device Software focuses on embedded ... technology to make global connectivity a reality. As a Device Software Development Engineer on the Kuiper...Mentor junior engineers, conduct design reviews, and uphold high software quality standards. This position requires that… more
- Amazon (Northridge, CA)
- …multidisciplinary team developing targeted and scalable solutions for custom satellite and ground applications . KGS Device Software focuses on embedded ... technology to make global connectivity a reality. As a Device Software Development Engineer on the Kuiper...Mentor junior engineers, conduct design reviews, and uphold high software quality standards. Security Clearance : This… more
- Amazon (Seattle, WA)
- …technical goals A day in the life As a Principal Product Manager - Technical in Device Operations Technology and Software (DOTS), you will work in a team of ... by internal and external analysis - Define creative, high quality , simple product roadmaps based on customer learnings, team...features. DOTS team has a singular mission of delivering software and business solutions for Device Ops… more
- Amazon (Sunnyvale, CA)
- Description Amazon lab126 Emerging Device Software team is looking for Senior Software Development Engineer to lead the design and architecture of new ... Software Engineer, you will design and develop high quality software . You will also have the... solution for our customers. About the team Emerging Device Software team owns all the components… more
- Hologic (Newark, DE)
- Senior Software Engineer, Medical Device Newark, DE,...develop and test them. + Design and develop high quality software . + Develop and maintain ... to offer job opportunities. We are seeking a **Senior Software Engineer (C#/ .NET, Full Stack)** to design, develop,...will work as part of a team developing user-facing applications for medical devices related to breast and skeletal… more
- Amazon (Seattle, WA)
- …goals A day in the life As a Sr. Product Manager - Technical in Device Operations Technology and Software (DOTS), you will work with business partners and ... by internal and external analysis - Define creative, high quality , simple product roadmaps based on customer learnings, team...Reverse Logistics, and (ii) Warranty Services. About the team Device Operations Technology and Software (DOTS) is… more
- Sanofi Group (Cambridge, MA)
- … device titration application . We are gearing up for other software applications across the diabetes and speciality care journey, with external LMR ... for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring...technical domains: + Medical devices and systems + Mobile device application architecture and security + IoT… more
- Amazon (Sunnyvale, CA)
- Description We are looking for a skilled and motivated Software Development Engineer to join Amazon's Smart Eyewear team. This is a unique opportunity to work on an ... in their daily lives. You'll design and build mobile and cloud software that integrates seamlessly with smart eyewear hardware, delivering best-in-class user… more
- Amazon (Sunnyvale, CA)
- …teams including developers, product managers, and project managers to understand software quality requirements and design effective test strategies. - ... establish new test frameworks and processes for testing new device and OS, find ways to leverage and scale...test effectiveness. A day in the life Our Senior Software Quality Engineers are world class … more
