Job Search Results for Biomedical engineering

Insight Global is seeking a Senior Quality Engineer to support a leading medical device manufacturer specializing in combination medical devices. This newly created role is focused on establishing a... More best-in-class approach to drug?device combination products, integrating pharmaceutical science, quality systems, and manufacturing execution. This role partners closely with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 4 requirements for drug-device combination products manufactured in the Urology business. The individual will lead quality and continuous improvement initiatives, serve as the technical quality lead during audits, analyze quality data and manufacturing metrics to identify trends and drive corrective actions, and collaborate with cross-functional teams to reduce defects, nonconformances, and customer complaints. Responsibilities also include developing quality plans, specifications, risk assessments, FMEAs, process monitoring systems, training materials, and quality tools; supporting product containment and release activities; evaluating the effectiveness of quality systems and manufacturing operations; and conducting internal audits to support ongoing compliance and continuous improvement within the client Quality System.This position is fully onsite in Arden Hills, MN, and offers a salary range of $100,000?$125,000 plus a 10% bonus, depending on experience.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 looking for a QC Analytical Investigator to sit on-site at a brand new facility in the beautiful Seaport district of Boston supporting one of our top pharmaceutical clients. This is... More a first shift role, on-site Monday through Friday. This position will be supporting the growing technical services team in their risk assessment efforts. This role will be responsible for conducting RCA, assessing impacts, and developing CAPAs to ensure efficient and effective processes across the cell and gene therapy organization. A strong candidate for this role will have a strong background in QC Analytical risk assessments, in GMP environment, leading, writing and reviewing deviations and investigations. Th This person will need to be comfortable managing several projects simultaneously with various stakeholders, maintaining a project management mind-set. Additionally, they should be comfortable working independently and confidently managing decisions on their own. This is an amazing opportunity for a mid-level professional to get their foot in the door at a fast-paced and high growth company and take the next step in their career!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

Hiring User Research Moderators to join a dynamic team in Irving, TX 75039 that specializes in wearable tech research studies! Schedule: Full time Mon - Friday, 8am -6pm*Project Duration: ASAP -... More September *potential extensions/additional phases to followOverview:We are seeking a detail-oriented and empathetic User Research Moderator to facilitate research sessions with participants testing a wearable prototype device. This role is critical to ensuring smooth study execution and gathering valuable insights for product development.Key Responsibilities:?Coordinate and conduct user study sessions, ensuring participants feel comfortable and informed.?Engage in one-on-one interaction with each participant throughout the session.?Instruct participants on how to interact with the study prototype device, following the research protocol.?Collect demographic information and take measurements of each participant?s hip and waist as part of the study requirements.?Observe and document participant interactions, behaviors, and feedback accurately.?Take detailed notes on errors, issues, and important information related to the specific protocol you are running.?Troubleshoot basic device issues during sessions and escalate technical problems when needed.?Maintain confidentiality and adhere to the organization?s standards.?Provide clear, concise summaries of findingsWe 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

This individual will support design verification activities for infusion-related medical devices and fluidic systems. While a separate team performs much of the formal testing, this person will be... More responsible for investigating test failures, determining root cause, and documenting findings.Key Responsibilities?Support design verification (DV) testing activities for infusion systems and related medical devices.?Conduct root cause investigations when testing failures occur.?Troubleshoot fluidic systems, including infusion sets and leak-related failures.?Determine: oWhich component is leakingoWhy the leak occurredoWhether the component was damaged prior to testing or during testing?Analyze mechanical and fluid dynamic performance issues.?Develop, improve, and debug test methods.?Generate technical documentation, investigation reports, and engineering summaries.?Collaborate with testing technicians and cross-functional engineering teams to resolve issues.?Utilize Design of Experiments (DOE) methodologies to evaluate system performance and failure modes.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

Our client is seeking an MQSA Engineer to join the Quality Systems team. This role ensures compliance with microbiological quality and sterility assurance standards across manufacturing and product... More development processes. The ideal candidate will have expertise in sterility assurance, microbiology, and regulatory compliance within a medical device environment.Key Responsibilities-Develop, implement, and maintain sterility assurance programs for medical devices in compliance with FDA QSR, ISO 13485, and ISO 11135/11137 standards.-Provide technical leadership for cleanroom validation, bioburden testing, and environmental monitoring programs.-Support sterilization process development and validation (e.g., ethylene oxide, gamma, steam, or gaseous sterilization methods).-Conduct risk assessments related to microbiological contamination and sterility assurance.-Collaborate with R&D, Manufacturing, and Quality teams to ensure sterility requirements are integrated into product design and production processes.-Author and maintain SOPs, protocols, and reports for sterility assurance activities.-Lead investigations for sterility-related non-conformances and implement corrective/preventive actions (CAPA).-Support internal and external audits, including regulatory inspections.-Provide training and guidance on microbiological quality and sterility assurance best practices.Compensation: $40/hr to $48/hr. Exact compensation may vary based on several factors, including skills, experience, and education.Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.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

Job OverviewInsight Global is seeking a Scientist I to support one of our top medical device clients, Boston Scientific, at their Arbor Lakes, MN location. This individual will join a research and... More development team focused on executing laboratory testing, method development, data analysis, and technical documentation in support of new and existing medical device projects.The ideal candidate will have a strong scientific background in Biology, Chemistry, or a related engineering discipline, prior medical device experience, and a hands-on approach to laboratory testing and problem solving. This role is highly collaborative and will require working cross-functionally with scientists and engineers to generate data, support experiments, and contribute to project deliverables.Note: PhD candidates will not be considered for this opportunity.Day-to-Day Responsibilities? Execute laboratory experiments, testing protocols, and routine scientific procedures under limited supervision? Support test method development and validation activities? Analyze experimental data, identify trends, and compare findings to historical data? Maintain detailed laboratory documentation including notebooks, reports, and technical records? Generate data summaries and contribute to technical reports, presentations, and project documentation? Assist with Design of Experiments (DOE) execution and statistical analysis activities? Collaborate with cross-functional R&D teams to support project goals and timelines? Support equipment maintenance, calibration, and qualification efforts as needed? Order laboratory supplies and support inventory management activities? Follow all quality, safety, and regulatory requirements while maintaining a clean and organized laboratory environmentWe 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

A large medical device company is seeking a Clinical Research Manager to support the planning, execution, and oversight of global clinical studies. This individual will be responsible for managing... More clinical trial activities to support the development, regulatory approval, and commercialization of innovative cardiac ablation technologies and electrophysiology products.The ideal candidate will have a minimum of 3 years of experience managing clinical trials within the medical device, biotechnology, pharmaceutical, or healthcare industry and possess a thorough understanding of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and global clinical research requirements.Key ResponsibilitiesLead the day-to-day management of clinical studies for electrophysiology medical devices from study startup through closeout.Develop and maintain study timelines, budgets, risk mitigation plans, and project tracking tools.Collaborate with cross-functional teams including Clinical Affairs, Regulatory Affairs, Quality, R&D, Biostatistics, Data Management, and Medical Affairs.Manage relationships with clinical investigators, research sites, contract research organizations (CROs), and external vendors.Monitor study progress, enrollment metrics, protocol compliance, and data quality.Ensure clinical studies are conducted in compliance with:FDA regulations (21 CFR Parts 11, 50, 54, 56, 812)ICH-GCP GuidelinesISO 14155Company SOPs and regulatory requirementsKey responsibilities:Review and contribute to study protocols, informed consent forms, case report forms, monitoring plans, and clinical study reports.Support adverse event reporting and clinical safety surveillance activities.Oversee clinical trial documentation including Trial Master File (TMF) management and inspection readiness activities.Participate in regulatory submissions, audits, and inspections.Analyze study performance metrics and provide status reports to senior leadership.Support publications, abstracts, investigator meetings, and scientific presentations related to clinical studies.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 looking to bring on a Secret cleared Radio Frequency Engineer to the team, in support of a Federal client. The RF Engineer will be responsible for conducting mechanical and/or... More electromagnetic modeling of RF waveform interactions with biology, or the ability to interpret and assess models, using statistical software for analyses and generating figures for diverse (and sometimes nontechnical) audiences, and maintaining data sets and complying with applicable regulatory entities in support of mission.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