Job Search Results for medical device regulations

We are looking for a talented MRI Electrical Design Engineer with over 10 years of experience to join our team. In this role, you will design, develop, and test high voltage electrical systems... More intended for compatible use with magnetic resonance imaging (MRI) scanners. You will replicate MRI scanner environments for medical devices using either current injection or radiated energy techniques, and will meticulously analyze the interactions to ensure electromagnetic compatibility (EMC) of the device. Your expertise will be crucial in labeling devices for different electromagnetic fields, including 3T higher resolution MRI, and understanding the impact of a wide range of frequencies on device performance. A comprehensive and in-depth knowledge of the electromagnetic fields generated by MRI scanners is required for success in this role. Additionally, collaboration with cross-functional teams will be essential to ensure cohesive product development and successful integration of electrical designs. You will support multiple workstreams as the MRI subject matter expert (SME), delegating tasks as necessary to ensure deliverables are completed on time.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

We are seeking an experienced Operations Supervisor to oversee 75% of our operations lifecycle, including staging, filling, demolding, and other processes. This role will manage a team of 20... More employees across four departments, ensuring efficient and compliant operations.Key Responsibilities:Supervise and coordinate daily operations across staging, filling, demolding, and other processes.Manage and lead a team of 20 employees, providing guidance and support.Ensure compliance with Good Manufacturing Practices (GMP) and quality standards.Oversee safety documentation and ensure adherence to safety protocols.Conduct regular quality checks and audits to maintain high standards.Collaborate with other departments to optimize workflow and productivity.Implement process improvements to enhance efficiency and reduce costs.Required Qualifications:Bachelor's degree in a related field (e.g., Engineering, Manufacturing, Operations Management).Minimum of [X] years of experience in manufacturing, preferably in the medical device industry.Proven experience in safety documentation and familiarity with GMP.Strong leadership and team management skills.Excellent organizational and problem-solving abilities.Effective communication skills, both written and verbal.Preferred Qualifications:Experience with quality checks and audits in a manufacturing environment.Knowledge of regulatory requirements for medical device manufacturing.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

About the Role: We are seeking a highly skilled and experienced Quality Engineer to join our team in the medical device industry. The ideal candidate will have a strong manufacturing background and a... More proven track record in quality engineering, particularly in the assembly of complex, low-volume medical devices. This role involves close collaboration with various teams to ensure the highest standards of quality and regulatory compliance for post market hemostasis products.Key Responsibilities:Reviewing Engineering Change Orders: Evaluate and approve changes to engineering designs and processes, ensuring compliance with medical device regulations.Attending Standup Operation Meetings: Participate in daily standup meetings to discuss ongoing operations and project updates.Joining Change Review Meetings for Software: Collaborate with the software team to ensure hardware and software integration is seamless, focusing on medical device functionality.Design Change Risk Assessments: Conduct risk assessments for design changes to identify potential issues and mitigate risks, adhering to medical device standards.Supply Chain Issue Resolution: Assist procurement in identifying and resolving supply chain issues, including inventory management, with a focus on medical device components.Performing Supplier Audits: Conduct FDA audits and ensure suppliers meet regulatory standards specific to medical devices.Manufacturing Background: Work closely with assembly teams to ensure quality standards are met for medical devices.GD&T Knowledge: Apply Geometric Dimensioning and Tolerancing principles in quality assessments for medical device components.ISO 13485 Compliance: Utilize ISO 13485 standards in quality management processes for medical devices.Assessing Changes Against ISO 14971: Evaluate changes against ISO 14971 standards to ensure risk management compliance for medical devices.Supporting Hemostasis Product Lifecycle: Focus on maintaining and improving the quality of 'on market' hemostasis products, ensuring their sustainability and compliance.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 Validation Quality Engineer to join one of our medical device clients to work on a class III device. The scope of the role is one specific, large PPAP (Production Part... More Approval Process) that must be completed by the end of September to support a regulatory submission that will be made by the customer in October.~80% of the candidates time will be spent writing test method validation (TMV) protocols, executing them, and writing the summary reports; the same for process validation. Their validation knowledge needs to be at a level where the candidate can complete those assignments with very little hand holding from the team beyond initial orientation to the project.Most of the rest of the PPAP work is complete, but the remaining tasks will take up ~20% of the candidates time and will include activities like Measurement System Analysis (MSA)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

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, however a bulk of the work for this current project will be in manual testing. 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 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 Technical Writer II to join a leading Medical Device manufacturing company. Responsibilities include writing, revising, organizing, and proofreading technical... More documents, and collaborating with the manager and a 40-member Project Manager Team (12 onsite daily). Key tasks involve planning and creating content using technical writing methods, accurately summarizing technical information, handling administrative tasks like routing documents for approvals, maintaining document quality, peer-editing other writers' work, and collaborating cross-functionally to gather information and understand products. Additionally, identifying and implementing innovative solutions to improve technical writing processes and ensuring compliance with all quality requirements are essential.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 Quality Control Inspector for a medical device client in the Irvine, CA area. They will be responsible for in-line inspections, both top assemblies and finished goods.... More This position is for 1st shift (7am-3:30pm, Monday-Friday). They will then learn and be apart of receiving inspections once comfortable with training.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 Master Data Services (MDS) Engineer located in either India or Brazil to join the team of one of our largest medical device clients. In this role, you will be responsible... More for managing and maintaining the Master Data Services (MDS) environment, ensuring data integrity, consistency, and accuracy across the organization. This role involves collaborating with various technical teams to optimize data management processes and support business initiatives.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 entry level engineering professional to work for a large life sciences company local to the South Orange County / North San Diego area. This person will be required to go... More on-site 5 days a week (some flexibility for working hybrid) and this will be a contract role with the potential of hire after 1 year. This person will be working with R&D engineering team to evaluate medical device products performance and limits. They will be performing testing daily on product samples using testing methods (Instron Tensile, Sprint Air, Crescent Water, Flow testing).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

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 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