Job Search Results for medical device

- Assist with testing and validation of medical devices prior to and during integration with clinical systems- Support the integration of medical devices into the hospital (OS/clinical) environment,... More ensuring proper functionality and data flow- Work closely with Biomedical Engineering (Biomed) technicians to configure, set up, and prepare devices for testing and deployment- Configure and manage IP network destinations for medical devices, ensuring accurate connectivity and routing- Support and troubleshoot Epic integrations related to connected devices and clinical data exchange- Knowledge of DICOM standards and how imaging/medical device data interfaces with clinical systems- Understanding of IP protocols, networking fundamentals, and device-to-system communication- Assist with issue resolution, testing documentation, and integration troubleshooting across environmentsWe 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

?Lead the design and implementation of embedded device security architecture from the ground up. This includes using the best industry standard cryptography practices for things like secure key... More management systems, hardware secure boot, PKI, efficient encryption of data, and more.?Collaborate cross-functionally with the CoreOS, Firmware, Design, and Cloud Services teams to create robust security features.?Develop custom TrustZone or native kernel applications to enhance hardware-backed identity solutions and data protection.?Work on high-profile projects, such as secure channels between devices, protecting personal data, and automatic theft detection; which all require secure and efficient data handling.?Interface with biometric sensors to create secure channels for data flow inside and outside device boundaries.?Assist in vulnerability management, and apply secure SDLC practices across the company.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

A global medical device manufacturing organization is seeking a Production Operator ? Catheter Manufacturing to support hands-on production at its Bedford, MA facility. This role is focused on the... More assembly and inspection of disposable catheter products in a cleanroom, regulated production environment. The ideal candidate is highly detail-oriented, comfortable with repetitive work, and experienced assembling small components using plastics, tubing, adhesives, and balloon catheter materials.This position supports production ramp-up and long-term stabilization of 2026 manufacturing volume.Compensation: $28/hr. to $30/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on day one 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

This position is essential to driving CAPA activities from issue identification closure, project manage CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during... More audits and CAPA review board meetings. Position to be home based in the USA. Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.?Screening Questions and Answers:1.What does CAPA stand for, and why is it important in the medical device industry?oCAPA stands for Corrective and Preventive Actions. It is crucial in the medical device industry to identify and eliminate the root causes of non-conformities and prevent their recurrence, ensuring product quality and regulatory compliance.1.Can you explain the difference between corrective actions and preventive actions?oCorrective actions address existing issues by identifying and eliminating the root cause of a non-conformity. Preventive actions are proactive measures taken to prevent potential issues from occurring.1.Process and Implementation1.What are the typical steps involved in a CAPA process?oThe typical steps include: identifying the issue, conducting a root cause analysis, developing a corrective/preventive action plan, implementing the actions, verifying the effectiveness, and documenting the entire process.1.How do you identify when a CAPA is needed?oA CAPA is needed when there is a significant non-conformity, customer complaint, audit finding, or any other indication of a systemic issue that could impact product quality or regulatory compliance.1.What tools or methods do you use for root cause analysis in CAPA investigations?oCommon tools include the 5 Whys, Fishbone (Ishikawa) Diagram, Failure Mode and Effects Analysis (FMEA), and Pareto Analysis.1.Regulatory Compliance1.Which regulatory standards and guidelines must CAPA processes comply with in the medical device industry?oCAPA processes must comply with FDA?s 21 CFR Part 820 (Quality System Regulation) and ISO 13485 (Medical devices ? Quality management systems).1.How do you ensure that CAPA activities meet FDA and ISO 13485 requirements?oBy following a structured CAPA process, maintaining thorough documentation, conducting regular audits, and ensuring all actions are traceable and verifiable.1.Practical Application1.Can you provide an example of a CAPA you have managed, including the issue, investigation, and resolution?oExample: A non-conformity was identified in a batch of medical devices due to a manufacturing defect. A root cause analysis revealed a malfunctioning piece of equipment. The corrective action involved repairing the equipment and retraining staff. The preventive action included implementing regular maintenance checks. The effectiveness was verified through subsequent batch testing.1.How do you verify the effectiveness of a CAPA once it has been implemented?oBy monitoring the process or product for recurrence of the issue, conducting follow-up audits, and reviewing performance data to ensure the issue has been resolved and does not reoccur.1.Continuous Improvement1.What role does CAPA play in continuous improvement within a quality management system?oCAPA is integral to continuous improvement as it systematically addresses and eliminates root causes of issues, leading to enhanced product quality and compliance over time.1.How do you document and track CAPA activities to ensure ongoing compliance and improvement?oCAPA activities are documented in a CAPA management system, which includes detailed records of the issue, investigation, actions taken, verification of effectiveness, and any follow-up actions. Regular reviews and audits ensure ongoing compliance and improvement.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 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. The ideal candidate will have a science-based background?such as pharmaceutical, chemistry, or combination product experience?and the ability to apply those principles within a medical device manufacturing environment.This role provides quality and process engineering support to product development teams within Urology and Cardiology, with responsibility for reducing manufacturing defects by leading root cause analysis and implementing effective corrective and preventive actions. You will develop and maintain product and process quality documentation, including specifications, risk assessments, and FMEAs, while establishing process monitoring systems to reduce variation and eliminate defect sources. The role also involves analyzing manufacturing quality data to drive continuous improvement, creating quality tools and training materials, and ensuring compliance with regulatory and company requirements. As the technical lead for combination products under 21 CFR Part 4, you will support audits, perform trend analysis, oversee corrective actions, and approve final process monitor releases prior to distribution.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

One of our large Medical Device companies is seeking a highly qualified Senior HMI Development & Integration Engineer to support the design, development, deployment, and sustainment of Human-Machine... More Interface systems utilized in the production of medical device products. The selected engineer will lead HMI development initiatives across a multi-vendor machine platform, drive standardization of HMI architectures on-site, and provide technical leadership throughout the full project lifecycle. This role is primarily focused on HMI system design, cross-vendor integration, and technical documentation in support of validation and qualification activities ? requiring advanced proficiency in HMI engineering execution, SCADA platforms, and regulated environment documentation practices. The engineer will be responsible for leading the design, development, programming, and documentation of HMI solutions across a multi-vendor manufacturing system comprised of three distinct vendor platforms. The candidate will serve as the primary HMI technical authority, responsible for harmonizing vendor-specific HMI standards into a unified, site-compliant solution. All work will be performed within a medical device regulated environment and must adhere to applicable internal procedures, GAMP 5, and GxP standards.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

A global medical device manufacturing organization is seeking a Production Operator ? Console / Electromechanical Assembly to support the build and assembly of medical device console systems at its... More Bedford, MA facility. This role focuses on lower-volume, more technical assembly work, including electromechanical components, electronic boards, and integrated systems.The ideal candidate has strong technical aptitude, is comfortable working in a regulated cleanroom production environment, and has experience assembling complex mechanical or electronic components.This position supports production ramp-up and long-term stabilization of 2026 manufacturing volume.Compensation: $28/hr. to $30/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on day one 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

A client of insight Global is looking for a Medical Device and IoMT Security Specialist to join their team. This person will be helping to set up a greenfield cybersecurity program for connected... More medical/IoMT devices within the company aligning with Clinical Engineering/Healthcare Technology Management (HTM) and IT.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

We?re supporting a fast-growing, mission-driven medical device company in the diabetes technology space that is seeking an experienced Design Verification (DV) Test Technician to support hands-on lab... More testing in a highly regulated environment. This person will work closely with engineers to execute mechanical performance testing for hardware components, following established test protocols and accurately documenting results. The role is heavily lab-based and focused on running verification and performance tests, maintaining lab equipment, managing test samples, and ensuring all work is completed in accordance with regulatory and documentation standards. This is not an assembly role - it requires strong mechanical intuition, attention to detail, and the ability to follow structured procedures precisely in support of product development efforts.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

The Principal Supplier Engineer serves as the technical lead responsible for integrating supplier designs, components, and manufacturing processes into regulated medical device products. This role... More partners closely with R&D, Quality, Operations, Regulatory, and external suppliers to ensure compliance with design controls, risk management, and global regulatory requirements. Core responsibilities include supplier design assurance, component and process qualification, validations, supplier audits, and CAPA investigations. The engineer evaluates supplier capabilities, manages supplier-driven changes, and mitigates supply and quality risks across the product lifecycle. This position plays a key role in ensuring product reliability, manufacturability, and patient safety while supporting new technology integration and commercialization.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