9 jobs found

Position Summary and Responsibilities: As a Software Engineer focused on our applications, you will report to Ceevra’s Chief Technology Officer. Your primary job focus will be on building the end-user client (desktop, mobile, and web) and back-end software that clinicians use, and on the automation frameworks for the validation of our machine learning models and other computer vision and graphics-related software. The responsibilities will extend to builds, deployments, data engineering, and the implementation of state-of-the-art machine learning models used to benchmark our software. Local candidates are preferred, although we’ll consider highly qualified remote candidates with at least two years of on-the-job experience. If local, we envision 3 days per week in our SF offices (or more if preferred by the candidate). Responsibilities Develop desktop, mobile, and web-based applications (front-end, back-end, and native apps) Work with the engineering team on...

Position Summary: As a Medical Device Software Quality Engineer, your primary job focus will be designing, implementing, and extending the medical device quality processes for Ceevra software that generates and displays 3D models of patient anatomy. Local candidates are preferred, although we’ll consider highly qualified remote candidates. If local, we envision 3 days/week in our SF offices (or more if preferred by the candidate). Responsibilities Drive quality-focused design and development of Ceevra software, including defining appropriate requirements, and creating and executing verification and validation plans and protocols Maintain and extend Ceevra’s Quality Management System Oversee various quality management activities, such as management reviews, internal audits, and external audits Develop quality practices applicable to cutting edge technologies with evolving regulatory guidelines such as Machine Learning Requirements At least three years...

What and who we are:   UltraLinq is a SaaS cloud-based medical image solution. We give our clients the ability to read, store, report and archive medical images anytime and from anywhere with an internet connection. We are a mature SaaS company with a startup mentality. Our team solely consists of passionate, motivated problem-solvers dedicated to providing exemplary service to our customers as we improve the healthcare experience for healthcare providers and professionals. We nurture a casual, diverse, and energetic atmosphere with highly supportive co-workers. Who we need:   We are currently seeking a Regulatory and Quality Assurance Specialist to join our team in our New York, NY or Durham, NC office. This is a great position for someone who enjoys working as part of a small team and leading in the maintenance and expansion of regulatory processes. Why you should apply:   If you are looking to make a significant impact in the Quality and Regulatory Assurance space, this...

Join a startup in Westchester County NY. Exciting growth opportunity. We manufacture a class II device with 510K clearance, CE mark under MDD. We are an ISO13485 facility. We're looking for someone who can help us navigate through the MDR process and maintain our QMS. We currently sell in 6 countries besides the US. Salary commensurate with experience - let's discuss.

Desktop Health is leveraging additive manufacturing and advanced materials to personalize patient care. Desktop Health is vertically integrated to develop, manufacture and commercialize applications across a range of healthcare specialties. The company is rapidly focused on leveraging its bio printing capabilities across several key specialties. Position Description: The Quality Assurance Manager will work with an interdisciplinary team to document the design and commercial manufacturing process of novel 3D printed tympanic membrane grafts (PhonoGraft) and other tissue grafts as part of the Desktop Health team. We are a small team located in Boston, MA (parking available), working to improve the lives of people with tympanic membrane perforations and other medical conditions. The candidate will work under the direct supervision of the Vice President of Biomaterials and Innovation, with support from a Manufacturing Engineer, a Mechanical Engineer, a Material Engineer, and...

Provide total quality and regulatory management and oversight for all aspects of ABM activities. Duties and Responsibilities: Establish clear outcomes and reliable milestones for all regulatory projects executed for and on behalf of ABM. Responsible for “bullet-proof” regulatory compliance in all aspects of operations, product development and acquisitions. Oversee the regulatory and quality team members as their activities and responsibilities relate to ongoing regulatory projects. Attend weekly Executive team, Staff, Regulatory, and Product Development meetings and other meetings as required. Participates in all aspects of the ABM Executive Team and staff to fully execute tasks to achieve ABM’s mission, goals and objectives. Ongoing Work Projects: Fully compliant regulatory systems USFDA QSR USFDA CGMPS ISO 13485 Canadian Medical Device Regulations – Medical Device Single Audit Program CE Marking from Medical Device Directive IMCAS...

Full Job Description: Enable Biosciences is an award-winning UC Berkeley/Stanford spun-out medical device company where we believe in providing affordable and accessible tests to empower timely diagnosis and treatment of difficult diseases. Based in South San Francisco, Enable leverages its patented ultrasensitive ADAP (Antibody Detection by Agglutination-PCR) technology to detect trace quantities of immunological biomarkers at the earliest treatable stage. Enable has been proudly offering its ADAP assays not only in its 10000 sqft CLIA/research lab but also in renowned institutes worldwide. Excellence of our products and service has been published in numerous peer-reviewed journals. Notably, Enable is proudly working with government entities to provide first-of-its-kind COVID19 testing service to support state-wide monitoring of disease prevalence and vaccination in the California. Enable Biosciences is seeking an experienced full-time Manager, Quality Assurance to join our...

Our innovative SaaS offering is poised to revolutionize the way that Medical Device companies invent, design, manufacture, sell, and support their wares. As we grow and expand our current offerings, we can offer a truly unique and exciting opportunity for experienced, entrepreneurial-minded software professionals to directly give form and shape to not only the products but to the culture and the company itself.   The  Medical Device Sales Engineering  role is a highly visible position within the sales organization. In this role, you will be responsible for demonstrating the software at a technical level to prospective clients. You will work with account executives to plan impact-driven presentations that are customized to each buyer. A strong understanding of software systems and user buyer habits is critical as well as having the ability to connect with buyers virtually and give world-class visual presentations of software (in a live environment). This...

Greenlight Guru’s presence in the Asia Pacific territory has grown significantly, and we are looking for a medical device professional to support our growing customer base there. This remote position gives the candidate flexibility to serve customers in those time zones best. The customer success team is distributed across the United States, and this position will help expand our global footprint. The Customer Success team within Greenlight Guru exists to ensure customers can achieve their desired outcomes by using our software, resulting in renewal and potentially expansion revenue.  The team is responsible for all facets of the customer experience, including training and onboarding, periodic business reviews, services and consulting, product roadmap prioritization and product testing, and reactive qualitative and technical support.  A  Medical Device Guru  is a specialized role within the Success team intended to bring industry expertise to the customer experience so...