- Medtronic (Newton, MA)
- …+ Collaborate with cross-functional teams, including hardware engineers, product managers, and quality assurance , to define software requirements and deliver ... hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, FDA regulations) is preferred but not… more
- US Tech Solutions (San Bruno, CA)
- …frameworks, and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in ... Assurance Champion:** 1. Act as a champion of Quality Assurance throughout the software ... software development, with a solid understanding of medical device software standards such… more
- Caris Life Sciences (Irving, TX)
- …outcomes. This role will be quality the subject matter expert for software development of medical device and computerized systems. **Job ... is where your impact begins.** **Position Summary** The Staff Software Design Quality Assurance Engineer...is a plus. + Working knowledge or familiarity with medical device software (IEC 62304)… more
- Stryker (Orlando, FL)
- …in a Medical Device (SiMD) and non- medical device software to support projects as a quality engineer for post-market activities to drive customer ... Quality Engineer, Post Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/ Software… more
- Insight Global (Golden Valley, MN)
- …field * 5 years minimum experience with medical device software quality or software design assurance role for finished medical devices. * ... device clients. This position is responsible for product software quality assurance support of...Comprehensive knowledge on medical software device design standards along with global… more
- Olympus Corporation of the Americas (Westborough, MA)
- … medical device setting. + Experience in the application of relevant standards to medical device software and non- medical device health ... . **Job Description** This role provides professional expertise for Software quality and best practices in SW...guidance, and leadership for the application of health and medical device SW regulatory standards to the… more
- Stryker (Redmond, WA)
- …code/vulnerability analysis and bug tracking tools. + Create efficient deployment processes for medical device software and ensure compliance with industry ... **What You Will Do** + Collaborate with Engineering, Operations, Quality Assurance , and Project Management teams to...+ Familiar with regulatory and compliance standards relevant to medical device software , including IEC… more
- Philips (Plymouth, MN)
- …Electrical etc.) + 8+ years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW ... to software , firmware, and hardware from a Software Design Quality Assurance perspective....Management for medical devices and IEC 62304 Medical Device Software . + Serving… more
- Stryker (Portage, MI)
- **Stryker** is hiring a **Senior Software Quality Engineer, Design Assurance ** to support our Medical 's Digital Health division and portfolio Software ... a Medical Device (SiMD) or Software in a Medical Device ...(SiMD) to execute on Digital Health projects as a software design quality assurance engineer… more
- Stryker (San Jose, CA)
- … Design Quality Engineer** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a ... (SiMD) to execute on Digital Health projects as a software design quality assurance engineer... regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device … more
- J&J Family of Companies (Cincinnati, OH)
- …Mentor members of the engineering staff to conform to Industry Standards for Medical Device Software (IEC 62304). **Qualifications / Requirements:** ... with our NPD teams to design and architect product software for use in cutting edge medical ...Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …DevOps, Jira or similar. **Preferred Skills/Experience:** + Experience in healthcare or medical device software and familiarity with regulatory standards ... us. **Job Summary:** We're looking for a highly motivated Software Product Owner to join our agile development team....in the medical device industry a plus + Advanced degrees or certifications… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ... experience in software engineering, information technology, or software quality assurance in a...Overview: This position offers a comprehensive benefits package including medical , dental, and vision insurance, a 401(k) with company… more
- Olympus Corporation of the Americas (Westborough, MA)
- …than 10 % **Preferred:** + MS in engineering or life sciences preferred. + Experience with medical device software , including software in a medical ... device (SiMD) and software as a medical device (SaMD), preferred. + Knowledge of regulatory submissions such as 510(k), De Novo, or CE marking for … more
- Insight Global (Golden Valley, MN)
- …field *12 years minimum experience a medical device software quality or software design assurance role for finished medical devices. ... device client. This position is responsible for product software quality assurance support of...*Comprehensive knowledge on medical software device design standards along with global regulations for … more
- Radformation (New York, NY)
- …engineer experience across multiple products * Familiarity with FDA Class IIa+ regulated medical device software * Building automation frameworks and ... QA Automation Engineer with a passion for software quality and test automation. In this...will vary for Canada-based candidates. Benefits include: * Multiple high- quality medical plan options with substantial employer… more
- ThermoFisher Scientific (Oakwood Village, OH)
- … device , GMP, EU Regulation or ISO 13485 background + Experience supporting medical device software and servicing preferred. + ASQ certification ... support them. **How will you make an impact?** The Quality Site Lead will lead in the implementation of...years of experience in a regulated environment such as medical device , biotechnology, or clinical. **Knowledge, Skills,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are established, ... medical devices, including stand-alone devices, combination devices, and Software as a Medical Device ...within a regulated healthcare environment, including 5-7 years in Quality Assurance or Compliance. + Proven leadership… more
- GE HealthCare (Bellevue, WA)
- … development and familiarity with Software Development Lifecycle (SDLC) in medical device or healthcare software development environment. + Experience ... This role will be the Quality Management Representative responsible for overall Quality Assurance activities at the Bellevue, WA office. They will stand up… more
- GE HealthCare (Cleveland, OH)
- …**Desired Characteristics:** + Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, ... Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software ... Device (SaMD) + Demonstrated understanding of Medical Device Quality Management System… more