- Oracle (Trenton, NJ)
- …and support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven ... Responsibilities: As a Principal Member of Technical Staff for Medical Device Software , your key responsibilities include: Architectural Leadership… more
- Medtronic (Newton, MA)
- …the Greater Boston area or have the ability to relocate for the position The Senior Software Engineer will be a key player in the Affera Software Team, working ... proficiency in Python and C++, and have a deep understanding of software engineering principles, including object-oriented design, data structures, algorithms, and … more
- Oracle (Indianapolis, IN)
- …Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). Experience working with AI-driven medical device applications or software as a medical device… more
- Oracle (Salt Lake City, UT)
- …Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). Experience working with AI-driven medical device applications or software as a medical device… more
- Hologic (Newark, DE)
- Senior Software Engineer, Medical Device Newark, DE, United States Located in Newark, DE, Hologic 's Innovation Center is continuing to offer job ... opportunities. We are seeking a Senior Software Engineer (C#/ .NET, Full Stack) to design, develop,...with secure coding principles or cybersecurity is a plus. Medical device experience is a plus. … more
- Stryker (San Jose, CA)
- … Device (SaMD)/ Software in a Medical Device (SiMD) and non- medical device software to support projects as a quality engineer for post-market ... using Power BI or similar tools for basic data visualization and monitoring. Exposure to Software as a Medical Device (SaMD), Software in a Medical … 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 ... guidance, and leadership for the application of health and medical device SW regulatory standards to the...as a Subject Matter expert on regulations around health software development, and software for medical… more
- Abbott (Alameda, CA)
- … software application issues to ensure the reliability and safety of medical device software products. Perform thorough testing of mobile ... Testing Preferred Qualifications Experience in testing mobile/web applications (ideally in medical device industry). Experience in writing, implementing and… more
- J&J Family of Companies (Danvers, MA)
- …Scrum Master, or equivalent project management certifications. Domain-specific certifications (eg, medical device software compliance, automotive safety ... Electrical Engineering, or related field. Experience: 10+ years in embedded software development in medical device domain. 4+ years in a leadership or… more
- Caris Life Sciences (Irving, TX)
- …(CDx) or NGS (Next Gen Sequencing) is a plus. + Working knowledge or familiarity with medical device software (IEC 62304) is a plus. **Physical Demands** + ... This role will be quality the subject matter expert for software development of medical device and computerized systems. **Job Responsibilities** + Authors… more
- Teleflex (Morrisville, NC)
- … market releases. **Principal Responsibilities** 1. Designs, develops, verifies, and maintains medical device software following industry best practices, ... ensuring scalability, reliability, and maintainability of software systems for connected medical systems. 2....aviation). **Specialized Skills / Other Requirements** - Experience with medical device regulatory standards such as 21… more
- Dentsply Sirona (Waltham, MA)
- …designing software architectures. Experience in leading technical teams. Experience in MD ( Medical Device ) software a plus. Key Skills, Knowledge & ... and oral health products as well as other consumable medical devices under a strong portfolio of world class...worldwide. We are looking for an experienced and talented Software Architect to join our team. This individual will… more
- Fresenius Medical Care North America (Lawrence, MA)
- …Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure compliant products, engineering teams ... performed, and actions derived PRINCIPAL DUTIES AND RESPONSIBILITIES Works as part of software development team on new product development or on design changes to… 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
- Hologic (Marlborough, MA)
- …and maintaining robust CI/CD infrastructure and development tools to support high-quality medical device software delivery. This role requires you ... control systems, especially SVN and Git, including migration strategies. Familiarity with medical device software development standards and regulatory… more
- Hologic (Newark, DE)
- …a Master's, or 3+ years with a PhD in program/project management, preferably in software or medical device industries. Proven experience leading large, ... SDLC stages. Experience with ISO, FDA quality systems, and medical device development cycles. At least 3...device development cycles. At least 3 years of software development experience preferred. Advanced knowledge of project management… more
- Oracle (Madison, WI)
- …ensure our software development practices meet the expectations for medical device safety, risk management, usability, security, and post-market ... Drive cross-functional alignment on regulatory, quality, and engineering needs for medical device -class software solutions. Establish program roadmaps,… more
- Medtronic (Lafayette, CO)
- …partnership with our project managers as a subject matter expert with our suite of medical device and software offerings Develop a deep understanding of the ... set up, configuration and deployment of both hardware and software -based products. This is both a challenging and rewarding...opportunity to demonstrate both technical proficiency and hands on medical device set up and deployment of… more
- GE HealthCare (Arlington Heights, IL)
- …The Program Manager is responsible for overseeing the end-to-end execution of GE HealthCare Software ( medical device software ) installation and upgrade ... hire Desired Characteristics Previous work experience managing / working in medical software domain with exposure to FDA or similar regulatory environment PMP,… more
- Terumo Neuro (Aliso Viejo, CA)
- …methods, including principles of formal computer software validation (CSV). Knowledge of medical device software regulations. 7. Strong ability to design ... and maintenance of enterprise systems, off-the-shelf applications, and custom/low-code software development. + Oversee design, implementation, and optimization of… more
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