Job Search Results for Medical device

Clinical Affairs Associate

A large medical device company is looking for a Clinical Affairs Consultant 3 to join their ultrasound team while sitting remotely. This position will be responsible for the clinical study design,... More development of study protocol and subsequent creation of clinical evaluation plans. This individual will lead interpretation of evidence generated from clinical evaluation plans and partner with internal teams to ensure accurate reporting of clinical data for marketing teams. This will also include determining clinical risk from life cycle management perspective. If this sounds like you, apply today!Less

Change Control Coordinator

One of our Medical Device clients is actively hiring for a Change Control Coordinator to join the Packaging team in Raynham, MA to help with documentation and basic administrative... More duties.Responsibilities include:- Understand release workflow structure in windchill- Single point of contact for Packaging Change Management activities- Collaborate with engineers on collecting right input workflow- To monitor progress towards project goals & objectives ensuring on time completion of project goals.- Coordinate between Windchill Change Owners, Windchill task assignees and Approvers as CR/CN manager ensuring a quicker completion of CR/CNs.- Identify right Windchill Task assignees and content approvers for various document types in Windchill CR/CN process.- Track the CR/CN process flow and resolve any issues to close the change process quicker.- Initiate Change Request and Change Notices for Packaging BOM and routing them for approvals and release in PLM system.- Upload models, assemblies and drawings in Windchill and process for approval- Maintain working relationship with windchill approvers at manufacturing and within the procurement, quality and regulatory organizations- Weekly updates on the project deliverables including being the primary coordinator for windchill release prioritization meetings.- Responsible for documentation & report generation- Initiate Change Request and Change Notices for Packaging BOM and routing them for approvals and release in PLM system.This position is fully onsite from Monday-Thursday & Remote on Friday.Less

Supply Chain Plan Analyst

Insight Global is looking for a Supply Chain Planning Analyst to assist in a large supply chain project for a medical device company located in Irvine, CA. This person will be working remotely until... More further notice. This candidate will be driving supply chain activities for assigned product portfolio including demand planning, new product launch planning, supply planning, inventory planning, and distribution planning. This person will be responsible for attaining and driving improvement to Key Performance Indicators, including forecast accuracy (MAPE, BIAS), inventory entitlement, Slow Moving/Obsolete (SLOB), and customer service (OTIF). They will also be supporting the Sales and Operations Planning (S&OP) process for assigned product portfolio in order to align market and financial requirements with manufacturing capabilities. Additionally, this person will be responsible for supply chain reporting including forecast waterfall, inventory, customer service (OTIF) fill rate, forecast consumption, and ad-hoc analysis. This person needs to have actual supply chain planning experience, and familiar with E2E supply chain principles.Less

Document Processor II

Document Control and Training Specialist In this role you have the opportunity to Lead global project execution and provide recommendations to management and business category leaders for Hospital... More Patient Monitoring HPM for projects including but not limited to Legal Manufacturing Consolidation and QMS Simplification. This position will work within a global network to communicate and address challenges related to strategic transformation and consolidation projects while driving standardization and compliance in the Business Group. You are responsible for bull Establishing and providing document control support to authors and process owners in defining and producing lean Quality System documents and records bull Ensuring and providing direction regarding proper quality of the content of documentation and records bull Establishing and managing proper document review processes bull Ensuring availability and publishing of controlled documents bull Establishing monitoring and responding to metrics on the efficacy and efficiency of the document management system and its ability to support the business bull Collecting and maintaining documents and records of the latest revision level bull Timely distribution of latest revision level documents and records to appropriate users and ensuring that obsolete documentation is removed from distribution and publication bull Maintaining the document management system an ensuring fast retrieval of documents and records bull Controlling issuance of document numbers including maintenance of proper document registers bull Ensuring proper document classification sorting filing and archiving in accordance with requirements bull Reviewing correct formatting and completeness of documentation bull Responsible for preparing document transmittals bull Archiving Quality records per process bull Accountable for transformation-related strategic initiatives supporting the PQMS structure bull Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS bull Ensures training and training registration as per the QMS and generates training content for QMS documents as necessary bull Approve each training material prior to usage and control the set and recording of approved trainings bull Ensure that training content is controlled and access to make changes is managed bull Ensure the assignment of training requirements profiles and documentation for all job required training bull Ensure that managers assign the correct training profiles to all individual employees based on job requirement profiles bull Report on training compliance and training related KPIs bull Ensure all mandatory training requirements are set and training is executed as required bull Administer both profiles and training records in line with regulatory requirements bull Ensure Training Management System setup in accordance with transformation of the QMS To succeed in this role you should have the following skills and experience bull Bachelors degree in a scientific or technical field or medical device certifications bull 3 years of experience in the medical device industry or similar work experience bull Strong working knowledge of GMPs and other FDA regulations bull Project Management Skills preferred bull Experience validating application activities. bull Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues. bull Experience in corrective and preventive actions including root cause analysis documenting findings/actions and implementing actions. bull Proven analytical capabilities bull Excellent communication organizational and project management skills bull Successful experience working with cross-functional teams across multiple work locations bull Network oriented and able to interact with different business functions and can work within numerous systems bull Work cooperatively in a team environment **Must be available to work East Coast Hours **Remote position** Experience: 2-5 years of experience in position or specialization. Education: High-school/Associates or equivalent experience if applicable. Certification if applicable. Open sort and route incoming mail answer correspondence and prepare outgoing mail. Complete and mail bills contracts policies invoices and checks. Compile copy sort and file records of office activities. Answer phones direct calls and take messages. Operate office machines photocopiers and scanners facsimile machines voice mail systems and personal computers.Less

Firmware Software Engineer V

Approved Meta Remote Locations: Denver CO 149.19 New York NY 165.48 Houston TX 149.19 Los Angeles CA 159.87 and San Diego CA 149.19. Must be a WEST coast candidate but is remote Summary: The main... More function of a firmware software engineer is to apply the principles of computer science and mathematical analysis to the design development testing and evaluation of the software and systems that make computers work. A typical firmware software engineer researches designs develops and tests operating systems-level software compilers and network distribution software for medical industrial military communications aerospace business scientific and general computing applications. Team Overview XR Camera Sensors builds the Camera and Sensor stack needed to power the various AR/VR products at Meta. Some of the devices we have shipped in the past include: Oculus Quest Oculus Quest 2 Facebooks first ever truly mobile and mass market VR Headset and the recently shipped Quest Pro Facebooks first Mixed Reality Device and Olympus controllers Self Tracked Controllers for VR Headsets. Some of the devices we are currently working on include future AR/VR devices and so many more New Technology InitiativesNTI. This team works on all things related to cameras sensors tracking input and imaging algorithms. We are a mix of embedded software engineers firmware enthusiasts systems generalists computer vision specialists/researchers and full stack engineers who come together and ship awesome camera experiences on our consumer electronics devices. Job Responsibilities: bull Review and approve the modification of existing databases and database management systems. bull Instruct staff to write and code logical and physical database descriptions and specify identifiers of database to management system. bull Direct database development and approve project scope and limitations. bull Review project requests describing database user needs to estimate time and cost required to accomplish project. bull Plan coordinate and implement security measures to safeguard information in computer files against accidental or unauthorized damage modification or disclosure. bull Approve schedule plan and supervise the installation and testing of new products and improvements to computer systems. bull Develop standards and guidelines to guide the use and acquisition of software and to protect vulnerable information. Skills: Working with AOSP codebase Operating with git repositories to do bisections Understanding C C Java and Python code Capable of efficiently reproducing bugs with some level of guidance on repro steps Understanding test-driven development and can write comprehensive automation tests in C Understanding of parallel programming: concurrency mutex condition variables race conditions Plus if skilled to do tracing on AndroidEducation/Experience: bull Bachelor's degree in computer science software engineering or relevant field required.Less

REMOTE Design Quality Engineer 2

In this Design Quality Engineer 2 - Risk Management role, you will be a quality engineer reporting into the Development Quality organization. You will be responsible for performing risk management... More activities associated with on-market in-vitro diagnostic (IVD) products ranging from Whole Genome Sequencing Platforms, Assays, Automation, and Software products in adherence to Quality Management System processes. This role will collaborate deeply with product SMEs in product development, manufacturing, as well as with Design Quality Engineering functions.This role requires an intimate understanding of the following: * Product Risk Management in accordance with ISO 14971:2019 * A highly disciplined approach to creating and maintaining risk documentation * The ability to quickly grasp highly technical concepts associated with a large product portfolio.Less

IT Customer Support Specialist

Insight Global is looking to add two IT Customer Support Specialists to the team sitting out of San Antonio, TX in support of a Federal client. The Desktop Support Specialists will be responsible for... More the following: Provide on-site hardware maintenance services on Government-Owned equipment utilizing Customer Support Service Specialists. ? The equipment to be serviced includes but is not limited to mini/microcomputers, handheld computing devices, optical technology, various controllers, plotters, printers, scanning devices, CD-ROM, video display units, information processing equipment, and related network devices and software and mobile devices like cell phones, smartphones, and pagers. ? Create a support request in the ticketing system during initial contact with the customer, except on weekends and holidays, in accordance with the local service level agreements. ? Participate in the flow of information by documenting all facets of support from initial contact, problem definition, problem resolution, and final disposition in the ticketing system, which will be available at all times to the government. ? Workstations shall be tested both in a standalone mode and as part of a network if initially connected. Any hardware repairs, additions, deletions, or modifications to the equipment shall include all necessary hardware and software (including network software configuration or installation). ? Participate in the development and sustainment of the ticketing system knowledge management system for both internal and external use. Install and troubleshoot all Microsoft Operating System Software and office automation software on the currently supported desktop. Install, configure and troubleshoot standard Network Protocols at sites, including, but not be limited to, TCP/IP and wireless protocols. Identify and resolve problems with all automation hardware, software, systems and peripherals, at the customer service support center, the customer site, or by utilizing remote tools. Respond to all repair requests by making initial contact with the customer by phone, email or in person within four (4) work hours of the documentation of the malfunction, if the equipment is located on the local campus. All other response times will be negotiated based upon the location of the customer, at the discretion of the Government for the most efficient and complete service for the customer. Identify when a device, connected to the facility LAN, must be repaired, added, deleted or modified, the contractor shall take into consideration the interaction with the network of all components and/or software of the information system to be repaired or modified. The contractor shall not interfere with the connectivity of a network device, except as required for the period during which the repair or modification is actually being performed. ? Identify when a peripheral such as a printer, point device, video monitor, scanner, etc., is to be repaired, added or modified, the contractor shall configure the peripheral to function with the system hardware and software. This may include setting or resetting hardware settings, either through an interactive process with the peripheral or elsewhere in the system. It may also be necessary to modify CMOS settings on some computers, and the process may also include the installation of software drivers and the modification of operating system or application software configurations. The contractor shall not, by installing software, cause an information system to be in violation of Federal copyright. ? Perform on-call duty on evenings, weekends, and holidays to provide guidance and support to customer support technicians on resolution of program/applications problems and/or failures, and may be required to return to the work site to resolve critical problems. Contractor shall submit overtime documentation to the first line supervisor for review, first line supervisor will send documentations for approval. ? Document all service requests received while in on-call status on weekends and holidays within first four hours of next business day. ? Create, modify, and delete Active Directory user accounts. ? Discuss proposed field modifications to equipment or software with Government leadership prior to making nonstandard repairs in the field. No field modifications shall be installed unless approved by the Government. ? Manage hand receipts and maintain accountability controls of all government owned hardware and software. ? Work as part of a team to deploy new computer systems and peripherals to users spread throughout San Antonio and the outlying areas.Less