Job Search Results for medical device regulations

Insight Global is looking for a Sr. Business Analyst to join a leading medical device manufacturing company within the PMO group. You will leverage Project Portfolio Management (PPM) tools and... More solutions to manage daily business operations, including financial support, project assistance, data analysis, and process improvement initiatives. Additionally, you will work closely with cross-functional teams to evaluate current processes and suggest new capabilities to boost the group's operational efficiency.Day to day you will be responsible for serving as the key point of contact for future training and support needs within the division by becoming an expert of the new PPM system. Lead and support the migration to this new Planisware-based PPM system. Collaborate with the Finance team to support the Annual Operating Plan, quarterly forecasts, cost center mapping, and monthly spending. Coordinate with internal and external tool developers to enhance current tools and implement new ones. Create and maintain portfolio analysis reports and dashboards using PPM/BI tools. Support the creation and closure of project codes. Develop training materials, templates, and best practices. Assist with ad-hoc requests and projects for the PMO team. Lead and support continuous improvement efforts for PPM tools, systems, and processes.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Insight Global is looking for a Lead NPI Engineer to travel 50% of the time to different manufacturing sites supporting the manufacturing and design transfer of medical devices. This person will be... More responsible for giving technical advise to manufacturing teams in the introduction of new medical products, as well as ensuring the adherence of regulatory standards, quality requirements and project timelines.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Overview:Were hiring two experienced Electrical Engineersone focused on Digital/FPGA design and one on Analog systemsfor a highly specialized team developing cutting-edge medical devices. The right... More candidates will have strong hands-on experience with PCB design, schematic capture, and component-level layout, including 0603-sized components. Youll work cross-functionally on full-cycle board development and testing.Qualifications: Bachelors degree in Electrical Engineering (required) 25+ years of experience in hands-on electrical hardware design Expert-level proficiency in Altium or ORCAD Experience working with 0603-size components Demonstrated experience designing boards with at least 4 layers Strong background in PCBA layout, design for manufacturability, and testingKey Responsibilities: Design and develop multi-layer PCBs (minimum 4 layers) using Altium or ORCAD Lead schematic capture, layout, and component selectionminimum 50 components per board Design with RF4 materials and 18 mil PCB thickness Execute and support PCBA layout and bring-up Collaborate with cross-functional teams to develop high-reliability boards for medical use Ensure robust documentation and adherence to design control processesRole-Specific Duties:Digital/FPGA Engineer: Develop and implement FPGA designs using Verilog or VHDL Write control logic from engineering drawings Strong background in digital controls and embedded hardware Hands-on with schematic entry and digital signal integrityAnalog Engineer: Design and test audio-level signal pathsfocused on performance and fidelity Evaluate frequency response and amplifier quality Design power supply circuits including DC-DC and boost converters Signal chain analysis and testing for human-body level applicationsWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Duties and Responsibilities include the below but are not limited to, as your manager may ask you to perform tasks outside of normal job description.Works independently with general instruction and... More broad work expectations. Configures the VIPER software specific to customer needs and/or Spectrum Medical goals. Configures Live Vue and collaborates with field clinical sales team optimize Informatics build. Works with other Spectrum Depts. on the development of IFUs, training materials, etc. for customer use. Travel to customer sites for implementations, training and/or support. Extended and overnight stays may be necessary. Assists and/or completes device connectivity and aids in whatever manner required for customer implementations. Assists with validation of software. Assists and tests customer settings before, during and after software updates. Provides customer support via phone, email and/or text to aid customers in troubleshooting and/or improving their experience and utilization of Spectrum software. Coordinate with other Spectrum Depts. to be sure any customer issues are reported and documented in compliance with Spectrum Quality Processes (SOP).Organizes and prioritizes tasks and meets deadlines. Coordinates training and meeting schedules. Takes ownership of trouble shooting and customer service to Users, advising on the clinical and technical use of Quantum Informatics, to include the Customer Support Line and associated documentation.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

The position is responsible for participating in the plants quality assurance program, ensuring that the medical device and processes meet quality control standards. Responsibilities include reading... More and comprehending instructions, following established procedures, selecting components according to specifications and required schedules, checking output to ensure the highest quality, maintaining equipment in good condition, keeping records of production quantities and time by recording all information on tracking sheets and in the database, reporting on issues, malfunctions, or defective parts, and performing other duties as requiredWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

We are seeking skilled and customer-focused Endpoint Technicians to provide hands-on support for workstation and device-related issues. This role involves break/fix troubleshooting, hardware... More deployment, and responding to service requests for workstations, printers, phones, and other endpoint devices. The ideal candidate will have strong technical skills, a proactive mindset, and a commitment to excellent customer service.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Insight Global is seeking an Oracle Applications Database Administrator for a for a direct-hire opportunity at one of our Healthcare Device clients based in Ohio. This role will be onsite 4-5x week... More at either the companys Dayton or Northern Ohio location. About 90% of this individuals time will be spent owning the operational tasks of the enterprise's Oracle Applications/EBS including: cloning, upgrades, deployment, and patching. -Designs, specifies, and configures the Oracle database, to ensure it is up and running well by performing activities related to day-to-day administration, monitoring, and maintenance of the companys Oracle R12.2 E-Business Suite (applications tier, middle-tier, and database tier). -Administers, installs, maintains, develops and implements policies and procedures for ensuring the security, availability and integrity of these environments. -familiarity with scripting languages and certificate management Other responsibilities will include: Manage and monitor SLAs for uptime and performance of the Oracle production environment.Perform root cause analysis, and resolution, for Oracle incidentsDetermines database structural requirements by analyzing client operations, applications, and programming; reviewing objectives with clients; evaluating current systems;Develops database solutions by designing proposed system; defining database physical structure and functional capabilities, security, back-up, and recovery specifications.Installs database systems by developing flowcharts; applying optimum access techniques; coordinating installation actions; documents actions.Perform day-to-day database administration and performance monitoring tasksResolves database performance issues, database capacity issues, replication, and other distributed data issuesThere will be an on-call rotation for this position.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Insight Global is seeking a Senior Electrical Engineer for one of our rapidly growing Medical Device clients in the Minneapolis area. This person will be joining the client's R&D organization and... More will work closely with the sales team as they capture a variety of projects from their respective partners. The Senior Electrical Engineer will design microchips as a part of the developing and manufacturing process of their partners. This role includes sourcing, scaling, and pricing, as well as educating clients on what can be produced and manufactured.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

A major telecommunications company is seeking a Full Stack Developer to join its Automated Continuous Validation & Testing team, with a focus on 70% front-end and 30% back-end development. The... More successful candidate will be responsible for designing, developing, testing, and documenting an internal application that delivers automation solutions to support the Advanced Engineering (AE) organization. Working in an Agile environment, this developer will primarily use React for front-end development and Node.js for back-end services. Key responsibilities include integrating cable device automation to support additional teams, creating dynamic forms and views within the test development module, and exploring AI-driven enhancements to improve user experience. The role involves 8090% hands-on coding and code reviews, making it ideal for someone passionate about building robust, user-centric applications.Pay Range: $40-50 / hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

A global medical technology company in San Diego is looking for a Senior Electrical Engineer to join their team onsite in Sorrento Valley. You will support R&D projects for existing product... More expansions and technology enhancements of the existing product line. Performs skilled electrical/electronic design duties with the use of applicable hardware tools/equipment under moderate engineering guidance.Actively participates and provides guidance in the development efforts from concepts to implementation as a project member Decomposes system requirements into straightforward subsystem and/or electrical specifications and rudimentary designs.Apply theoretical and hands-on electrical support to identify problems and accomplish tasksGenerates schematic and related files that are ready for PCB layoutDrive PCB layout to the release of a PCBA fabrication package using Allegro CadenceDevelop and execute test documentation for electrical design verificationUnderstand and follow BD processes, design practices, and documentation templatesPerform and/or direct engineering documentation in SAP: create/change material, BOM, plans, and reports; process change orders; and design reviewsCollaborate with other engineers and departments to advance projects/tasksTime management of several assignments having varying scope and limited complexityProvide technical leadership across multiple projects simultaneouslyInterface with external design partners and suppliersWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less