Job Search Results for medical device regulations

We are looking for a mid-level Embedded Software Test Engineer to join a close-knit test team at one of our largest medical device clients. These testers will be responsible for ensuring the quality,... More privacy, compatibility, and reliability of all medical devices. This candidate should be skilled with manual and automation testing, as well as writing and understand the test cases and stories. The ideal background will be with C/C++/C# languages. Day-to-day responsibilities are as followed:Develop and follow through with manual and automated test plans, test cases, and test scripts for embedded firmware in the medical industry.Collaborate with other teams involved in the SDLC to help drive streamlined solutionsPerform code reviews with focus on quality, FDA standards, compatibility, and security.Analyze test results and share with stakeholders to clearly describe results and provide recommendations, along with comprehensive documentation.Daily agile and SDLC responsibilitiesWe 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 HR@insightglobal.com. 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 Quality Engineer to join one of our contract manufacturing medical device clients. You will support the activities and effectiveness of business processes (i.e. NMR,... More Complaint Investigations, CAPA, Process Qualification & Validation, Process Control & Monitoring, Engineering Change Control, etc) directly supporting the production business and manufacturing lines. You'll collaborate with a variety of engineering organizations to assure clear, effective, and consistent documentation practices are utilized within production processes. In addition you will support continuous improvement projects associated with improving the efficiency and removing waste from quality management system processes. You'll be supporting internal quality audits, as required by the annual schedule. You'll serve as quality review and approval authority for assigned product lines in support of the manufacturing cell and serve as the Quality point of contact with production customer organizations.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 HR@insightglobal.com. 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 a Project Scheduler to support the expansion of our medical device manufacturing facility. This role will work closely with Validation Engineers to develop and maintain project... More schedules, ensuring timely execution of validation activities, regulatory compliance, and seamless integration of new systems within the expanded site.Key Responsibilities:-Collaborate with Engineering personnel to align project schedules with validation protocols and regulatory requirements.-Develop and maintain detailed timelines for site expansion activities, including equipment installation, commissioning, and qualification.-Track progress, identify potential delays, and implement corrective actions to keep the expansion on schedule.-Ensure compliance with FDA, ISO, and GMP regulations throughout the validation process.-Coordinate with cross-functional teams (engineering, quality assurance, operations) to ensure smooth execution of expansion plans.-Utilize Microsoft Project to create, update, and analyze project schedules.-Experience with Smartsheet is preferred for enhanced project tracking and collaboration.-Prepare reports and presentations on project milestones, risks, and resource allocation.-Support risk management efforts by identifying scheduling conflicts and proposing solutions.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 HR@insightglobal.com. 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

An employer is looking for a Proposal Specialist/Business Representative to join their lab located in Midland, MI. This individual will join a team that writes proposals for chemistry focused studies... More for the following disciplines: consumer products, medical device, pharmaceuticals, specialty chemistry and bioanalytical. A request will come through the website/email and this person will meet with the client to gather specific specs that they are looking to uncover in the study. Then, you will either connect with the lab analyst to discuss how they would conduct the study or use your prior chemistry knowledge to write a proposal for how the study would be conducted. You will also include pricing in the proposal. Once the client accepts the proposal, the lab will begin working on the study. When the lab delivers the study to the client, you will be paid commission for the deal. You could work on anywhere from three to twelve proposals in a day depending on your experience level and the complexity of the proposal. 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 HR@insightglobal.com. 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 SME in Corrective and Preventative Actions (CAPA) to analyze and advise involved teams throughout the various end-to-end CAPA investigation processes. The responsibilities... More of this person will be as follows:- Complete product and process CAPA review tasks such as identifying issue descriptions, reviewing data, facilitating root cause analysis, advising on solutions, implementing solutions, and effective monitoring of the product post-CAPA- Initiative CAPA investigations and advise on solutions to cross-functional teams- Manage CAPA activities across all cross-function teams, including scheduling CAPA team meetings, ensuring the deliverable timeline will be met, ensuring effective monitoring post analysis, represent the CAPAs during audits and Review Board meetings, and mentoring the team throughout the analysis process- Confidently work in a high pressure environment while delivering on multiple projects with urgencyWe 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 HR@insightglobal.com. 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 an Electrical Design Engineer in St. Petersburg, FL. This person will be doing component selection, hardness design, requirements generation and conducting EMC testing... More for a medical device. This device has an existing design they are working on a redesign for a portion of the device and it will also require integration. Some schematic capture and circuit board design may also be required.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 HR@insightglobal.com. 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 large medical device manufacturing company is seeking an IT Service Delivery Administrator to join their team and work out of Fort Wayne Indiana, 5 days a week supporting one of their core... More locations. This individual will be providing in person support to employees of that location with technical resolution. One will be responsible for effective provisioning, installation/configuration, operation, and maintenance of peripherals, desktop hardware and software, data communication networks and related infrastructure. In this position you will work independently at times and be a key stakeholder representing IT in supporting business continuous improvement projects while aligning them to IT standards and best practices. Pay rate: 30-35/hrWe 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 HR@insightglobal.com. 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 Application 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 at... More either the companys Dayton or Northern Ohio location. About 90% of this individuals time will be spent owning the Oracle Applications/EBS in cloning, upgrades, deployment, and patching. Including:-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 HR@insightglobal.com. 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

Our client is a Global Medical Device Company. Comprised of over 6,000 dedicated employees, their mission is to make it possible to detect, diagnose and treat illnesses and other health conditions... More earlier and more effectively. The Internal Service Engineer will sit onsite in Marlborough and will be responsible for advanced troubleshooting to repair, test and qualify medical device instruments in the lab. Additional responsibilities include: ? Schedules and manages preventive maintenance on internal instruments. ? Works with Engineering to resolve quality issues and advise of issues and developments. ? Keep management advised of issues and developments. ? Ensure instrumentation is in compliance with regulatory requirements and quality control standards.? Creates, edits and validates Technical Documentation.? Creates system validation plans and reports.? Performs system validation testing.? Provide support to Product Development Engineers. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. ? Sit; use hands to finger, handle or feel objects, tools, or controls.? Lifting/moving and carrying products weighing up to 40 pounds.? Exposure to moving mechanical parts, vibration and/or moderate noise levels.Compensation: $45/hr to $65/hrExact 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 HR@insightglobal.com. 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 Inventory Technician Associate works as a part of the Inventory Technician Team on projects where TRIMEDX installs and maintains asset monitoring tags for existing clients, under the supervision... More and direction of leadership. Duties include but are not limited to inventory projects at designated customer sites, validation and inspection of medical equipment with an TRIMEDX asset tag and ensuring the asset tag is matched up with the device ID as listed in our CMMS system.Responsibilities Attend all identified asset tag installation sites and review assets as part of the project team. Follow TRIMEDX process for validating of existing medical equipment asset tags and perform corresponding matching process withing TRIMEDX CMMS system. Ensure attention to detail when reviewing tags and devices, and matching identifiers in TRIMEDX systems. Ensure understanding of in-scope devices to be tagged and/or scanned. Communicate process improvement ideas and flag identified risks to designated leader in charge. All other duties as assigned.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 HR@insightglobal.com. 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