Job Search Results for medical device regulations

Medical Affairs Scientist? Reprocessing

A large medical device company is looking for a Medical Affairs Scientist specifically supporting their Reprocessing business. They will serve as a scientific and medical affairs leader, responsible... More for the strategic generation, validation, and dissemination of clinical, preclinical, and bench-top evidence supporting the safe and effective reprocessing of diagnostic catheters. This role sits within Medical Affairs and works cross-functionally with R&D, External Research, Marketing, and Commercial teams to ensure scientific rigor, regulatory alignment, and credible medical-to-medical engagement with external stakeholders. This individual will translate deep technical and scientific expertise in device reprocessing into compelling, evidence-based narratives that demonstrate product performance, safety, and clinical relevance to clinicians, hospital systems, and scientific audiences.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

Senior WPF Software Engineer ? C#/.NET (Medical Imaging)

Insight Global is hiring a Senior Software Developer with strong C#/.NET WPF expertise for our medical device client?s next generation advanced neurosurgical product. This position will function as a... More fully remote contracted member of the software R&D team through December 2026.This role is primarily focused on frontend development of an existing Windows 10/11 C#/.NET WPF application, with responsibilities centered on the design, enhancement, and maintenance of a complex graphical user interface used for the manipulation and visualization of DICOM data and MRI thermometry using ITK and VTK.Development tasks include requirements and risk analysis, design, code, unit testing, verification, and documentation of all software activities. This individual will play a key role by providing technical leadership and guidance, as required, in the development of complex, safety-critical medical device software. The role requires close collaboration with other software developers, systems engineering, quality and design assurance, and cross-functional stakeholders.Key Responsibilities: ? Design, develop, and enhance C#/.NET WPF user interfaces that are intuitive, performant, and optimized for complex medical imaging workflows.? Implement frontend UI components that display and interact with VTK-rendered imaging data within a Windows desktop application.? Participate in the identification, design, and implementation of software requirements and specifications.? Follow all applicable Monteris quality system standard operating procedures as well as relevant standards, regulations, and guidance documents. As patient safety is paramount, apply a high level of judgment, responsibility, and professionalism.? Develop source code using approved software configuration management tools in a regulated development environment.? Translate software requirements and design specifications into robust, maintainable implementations.? Perform code walkthroughs and peer reviews, with an emphasis on frontend UI quality and maintainability.? Ensure the final product meets Monteris-specified requirements and verification criteria.? Participate in risk planning and mitigation activities as requested or required.? Perform other duties as requested or assigned.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

Project Manager (INTL - Mexico)

Insight Global is seeking a Project Manager to support our Medical Device client. This consultant will sit remotely in Mexico and should have experience in a medical device environment, ideally... More supporting Quality Systems?related initiatives. This role will manage multiple, overlapping projects and work closely with senior stakeholders to drive execution and visibility. Day to day will consist of the following: Responsibilities-Manage multiple concurrent projects within a regulated medical device environment-Coordinate and communicate with senior-level stakeholders across teams-Develop and maintain project plans, timelines, and status updates-Prepare and coordinate slides, decks, and executive-ready presentations-Track risks, dependencies, and deliverables across initiativesCompensation: $16/hr to $20/hr. Exact compensation may vary based on several factors, including skills, experience, and educationWe 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

Project Manager - LMS (INTL - Mexico)

Insight Global is seeking a Project Manager to support our Medical Device client. This consultant will sit remotely in Mexico and should have experience in a medical device environment, ideally... More supporting Quality Systems?related initiatives. This role will manage multiple, overlapping projects and work closely with senior stakeholders to drive execution and visibility. Day to day will consist of the following: Responsibilities-Assist with creating training packages for internal enterprise customers, specifically centered around ComplianceWire and additional LMS system-Manage multiple concurrent projects within a regulated medical device environment-Coordinate and communicate with senior-level stakeholders across teams-Develop and maintain project plans, timelines, and status updates-Prepare and coordinate slides, decks, and executive-ready presentations-Track risks, dependencies, and deliverables across initiativesCompensation: $16/hr to $20/hr. Exact compensation may vary based on several factors, including skills, experience, and educationWe 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

Epic Beaker DI Analyst

The Beaker DI Application Analyst plays a key role, using their integration expertise to support the foundational Device Integration buildout for lab workflows, laboratory instrumentation and LIS... More capabilities. The position will support the transition of integrated lab instrumentation from the current state to Epic Beaker/Data Innovations for the Pathology Lab. This role is a member of the Middleware and Data Innovations (MDI) team. A basic understanding of networking and IT infrastructure is preferred to assist with connectivity and troubleshooting.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

Sr. IoT Engineer- India

The IoT Senior Engineer is a key member of the Digital Engineering team responsible for the design, development, implementation, and support of Internet of Medical Things capabilities. This role... More focuses on secure edge-to-cloud connectivity, device lifecycle management, and cloud platform integration within a regulated medical device environment. The Senior Engineer contributes to high-quality, innovative, and scalable IoMT solutions aligned with the overarching reference architecture, development standards, cybersecurity requirements, and regulatory constraints. The position requires strong hands-on engineering capabilities across edge software, cloud services, secure connectivity, and containerized deployments. The role works closely with global R&D teams to enable new connected products and digital services.Compensation:$8/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st 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 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

Clinical Research Specialist

A large medical device company in Irvine, CA is looking for a HYBRID Clinical Research Specialist. This candidate will play a crucial role in supporting a 10 year post market clinical trial for... More breast implants. Their key responsibilities will include monitoring clinical studies, data verification, regulatory compliance, study documentation, site visits and coordination, and developing written travel reports.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

Senior Clinical Trial Leader

One of our large Life Sciences clients is looking for a Senior Clinical Trial Leader to help support a medical device cardiovascular clinical trial . This individual will manage day-to-day operations... More of said clinical trials, including budgets and oversight of Clinical Research Associates (CRAs) and other operational team members. They will collaborate with cross-functional partners to ensure smooth execution of trials and oversee Trial Master Files (TMFs), payments, and ensure all documentation is cleaned up and organized. They will ensure adherence to IDE regulations, focusing on patient safety and regulatory compliance and prepare comprehensive reports and updates for stakeholders.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

Design Quality Engineer - Risk File Remediation

Insight Global is seeking a Senior Design Quality Engineer (DQE) to support risk management file remediation efforts for a medical device product line of one of our Medical Device clients. This... More consultant will lead end-to-end remediation of risk files to ensure alignment with ISO 14971 and regulatory expectations. This role requires a highly independent Design Quality professional who can take full ownership of risk documentation, facilitate cross-functional PFMEA sessions, and drive alignment across Engineering, Quality, and Regulatory stakeholders. While the role is largely remote, candidates with proximity to Livingston, NJ or Trumbull, CT sites will be preferred due to faster product familiarization. They will own and execute full remediation of product risk management files, including:Risk Management PlansHazard AnalysesRisk Management ReportsDFMEAs and Use-Related FMEAsReview existing risk documentation, identify gaps, and update files to meet ISO 14971 and regulatory standardsFacilitate cross-functional PFMEA workshops, partnering with Design Engineering, Manufacturing, Quality, and Regulatory teamsDrive risk alignment discussions and ensure consistent hazard traceability across design and use risksInterface with stakeholders to gather inputs, resolve discrepancies, and finalize inspection-ready risk documentationEnsure remediation activities are completed efficiently with minimal oversightWe 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

Senior Epic Beaker DI Analyst

The Senior Beaker DI Application Analyst plays a key role, using their integration expertise to support the foundational Device Integration buildout for lab workflows, laboratory instrumentation and... More LIS capabilities. The position will support the transition of integrated lab instrumentation from the current state to Epic Beaker/Data Innovations for the Pathology Lab. This role is a member of the Middleware and Data Innovations (MDI) team. A strong networking and IT infrastructure background is preferred to ensure connectivity, security, and performance of integrated lab systems.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