Job Search Results for medical device regulations

Day to day:A client in the greater New Berlin, WI area is looking for a Lead R&D Engineer to join their team. This is full time and will be hybrid (3 days a week in New Berlin, WI). This resource... More will be responsible for below:Essential Duties and Responsibilities:Lead team of engineers, designers, and/or technicians in the development of Permobil Seating and Positioning products. This role includes both individual contributions to and management of design, evaluation, and testing activities. You will work closely with cross-functional teams, including Marketing, Quality, Operations, and Sourcing to ensure that our products meet the highest standards of quality and performance. The ideal candidate will have a strong background in medical device development, excellent problem-solving skills, and the ability to drive projects from concept to completion.-Lead the design, development, and testing of new Seating and Positioning medical device products from concept to production-Conduct research to identify technological advancements that address new and unmet user needs-Manage project plans, including timelines, budgets, and resource allocation to ensure successful project completion-Collaborate with cross-functional teams, including regulatory, quality, and manufacturing to ensure compliance and successful product launch-Mentor and guide a team of engineers, providing technical expertise and fostering a collaborative environment-Prepare and present technical reports, documentation, and presentations to stakeholders-Stay current with industry trends, standards, and regulations to ensure the company's products remain competitive and compliant-Develop and validate prototypes through testing and analysis using standard engineering tools-Troubleshoot and resolve technical issues that arise during the development processWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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 seeking a Chemical Manufacturing Engineer for a long term opportunity in the Greenville, SC area. This Manufacturing engineer will be located on site at the supplier for a leader in... More the medical device industry. They will be tied to the supply chain organization that has project management and project plans in place but the gap in the project is local support to launch a new product to market come 2027. This chemical manufacturing engineer will serve as the on site point of contact to drive project execution, troubleshoot any process implications and assist with any manufacturing issues that may arise. The supplier is a specialist in injection molding and foaming components for the medical device product that is being launched to market to assist with patient surgeries. Day to day responsibilities can include install qualifications, operational qualifications, performance qualifications, troubleshooting mechanical or software issues on site and reporting overall project scheduling updates to the home office in Cincinnati, OH. A background in chemistry, chemical engineering, or materials sciences is ideal for this candidateWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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 Director of R&D for a medical device manufacturer in the greater Nashville, TN area. In this role, you will lead a multidisciplinary engineering team in designing and... More developing innovative mobility solutions from concept through commercialization. This role drives strategic direction, oversees new product development and sustaining engineering, and ensures the product portfolio remains cutting-edge. You?ll collaborate cross-functionally with Marketing, Operations, and other teams to bring transformative assistive technologies to market, while fostering a culture of innovation and technical excellence. With access to state-of-the-art tools and a talented team of electrical, mechanical, and software engineers, you?ll make a meaningful impact in a fast-paced, mission-driven environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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 project manager to support a large life sciences company local to San Clemente / Northern San Diego area. This person will be required to work a hybrid schedule and come... More on-site 3 days per week. This role will be supporting outlining projects (2-3 active) for a specific medical device business line. This person needs to have an engineering background and is preferred to have a medical device background in order to understand timelines, initiatives, etc. This is a 12 month contract with the high chance of extension, and potential for full time hire.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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 diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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

Hearing Services - From newborns and children to adults and seniors, our experienced audiologists have the expertise, technology and care to bring you from silence to better hearing by... More providing:--Diagnostic balance testing to identify and treat imbalance problems and dizziness associated with your hearing loss. Using videonystagmography testing (VNG)--Extensive hearing testing/evaluations - You?re welcome to bring a loved one to your consultation as well. Family and friends provide specific insight into your hearing loss that will help your audiologist address your condition. --Hearing device demonstration - Typically done after a hearing test, this allows the user to experience new technology for themselves in a live listening environment with devices set for their own unique hearing needs.--Programming and fitting of hearing aids - Our team of audiologist will work with you to customize the settings of your hearing aids so your devices will be well adjusted and ready to take on and adapt to different listening environments.--Hearing aid consultations - Our follow-up appointments are intended to ease your transition period after you receive new hearing aids. Your ears and brain need time to adjust to hearing the sounds you?ve been missing.--Warranty programs--Hearing aid batteries and accessory sales--Hearing aid battery recycling--Comprehensive follow-up care, including regular hearing aid cleanings and adjustments, as well as annual hearing screenings.--Hearing aid repairs--Earwax removal--Redux moisture removal systems for hearing aidsWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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 Project Manager to support a leading medical device manufacturing company. The role begins with ownership of three small-scale projects, where the primary focus will be... More driving them to completion. Once those are finalized, the Project Manager will take full responsibility for a compliance initiative, managing all aspects including documentation, scope, and timeline from start to finish. On a day-to-day basis, the Project Manager will oversee project timelines, scope, and resource allocation, while also managing supplier quality engineers and internal quality engineers. The role includes leading internal team meetings and external stakeholder discussions, as well as presenting project updates twice a month to leadership. Pay rate $30-$38/hrWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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 detail-oriented and motivated Microbiology Laboratory Technician to join an established medical device company in Mundelein, IL. This role involves performing... More microbiological testing and analysis in support of medical device production. The ideal candidate will have a strong foundation in aseptic techniques and regulatory compliance and be comfortable working both independently and collaboratively in a fast-paced lab environment.Responsibilities: Conduct routine microbiological testing including environmental monitoring, bioburden, and endotoxin testing, specifically USP , , testing.Prepare and maintain culture media, reagents, and laboratory equipment.Document and analyze test results in accordance with GMP and GLP standards.Support investigations and troubleshooting of microbiological issues.Maintain accurate and timely records in compliance with regulatory requirements.Collaborate with cross-functional teams to support product development and quality control.Participate in internal audits and contribute to continuous improvement initiatives.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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

One of our large medical device clients is seeking an engineering technician to support new produce development and formulation teams in the development of new polymer-based products. This role... More involves managing materials, lab-scale and pilot-scale technologies, and collaboration with scientists and engineers to advance this project. This will be a 12 month contract to start.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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.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