Job Search Results for medical device regulations

An employer is seeking a Field Data Engineer for a long term opportunity in the Cincinnati, OH area. This Data Engineer will be tied to multiple NPD projects for a medical device leader and will... More report into the Data Lead over the program. The Field Data Engineer will be required to establish consistency, structure, and scalability across how data is collected, stored, processed, and prepared for deeper analytics. This individual will own the end-to-end data lifecycle for field and test data, driving standardization and enabling reliable downstream analysis. While this is an individual contributor role, it requires strong leadership, initiative, and the ability to independently prioritize work across multiple stakeholders as the stakeholders they will be working with are mechanical and test engineers. Ideally someone with 2+ years in a testing role will be the correct fit for this role. The main responsibilities will include:Data Collection - establish and enforce data collection norms, streamline existing collection processes and participate in data collection. This will be performed utilizing python, git, SQL or other data engineering toolsData Storage: compile, clean, organize, and develop data pipelines and database schemas coming from ~10 collective test stands, including offline equipment. They will also support data transfers via USB and other offline methods, ensuring integrity and traceabilityWe 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 Manufacturing / Validation Engineer to support a top medical device manufacturing client in Raynham, MA. This individual will play a critical role in the launch of a new... More production line, supporting the installation, commissioning, and qualification of new manufacturing equipment. The engineer will work cross-functionally with Quality, Commissioning, and Operations teams to ensure equipment meets regulatory and internal standards and is fully production-ready. This is a hands-on, high-impact role ideal for someone who thrives in fast-paced, highly regulated environments and enjoys bringing new manufacturing capabilities online.Compensation: $45/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

Insight Global is seeking a detail-oriented Tester/Systems Analyst?to join the Global Clinical IT team for one of our medical device clients. This role requires a detail-oriented Tester / Systems... More Analyst?to join the Global Clinical IT team supporting a leading medical device client. This role focuses on mapping clinical trial data from source systems to target platforms, defining transformation rules to align data with the target data model, and validating data accuracy through comprehensive testing. The ideal candidate brings strong experience working with Oracle databases, Tableau reporting, and end-to-end data pipelines?(including ingestion, transformation, monitoring, and validation). This position is heavily focused on data mapping and testing, with minimal involvement in requirements gathering.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 an experienced, highly skilled Sr Quality Engineer to support an established medical supply client out of Redmond, OR. Key Responsibilities:Develop and implement procedures... More for QMS, process control, validation, improvement, testing, and inspection.Partner with suppliers to resolve quality issues, ensuring corrective actions (CAPA, SCAR) are implemented.Provide Quality expertise in Product Development, Design Control, Risk Management, Validation, and QMS processes.Build and maintain Device Master Records (DMRs) in compliance with regulations.Collaborate with Regulatory Groups and internal departments to support 510K submissions and related documentation.Ensure compliance with domestic and international regulations.Perform quality reviews of design documentation, validation documentation, and company quality records.Lead investigations of product/process non-conformances and out-of-specification results.Develop and implement effective corrective and preventive actions.Train and mentor team members and employees on quality processes and best practices.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 qualified QC Chemist to join an established medical device company in Mundelein, IL. This individual will be responsible for conducting chemical analysis on raw materials,... More finished products, and stability samples. Duties include assay, quantification of materials, documentation of results, and general laboratory housekeeping.Responsibilities: Conduct chemical analysis on raw materials, finished goods, stability, and R&D samples.Follow all procedures related to data documentation, laboratory safety, and good laboratory practices.Review test data, calculations, and results for accuracy and completeness.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 macOS Endpoint Engineer (Workspace ONE) for a large, enterprise environment. This highly hands-on role will focus on designing, managing, and optimizing macOS device... More management at scale using Workspace ONE UEM. The engineer will play a key role in automation, security compliance, device lifecycle management, and advanced troubleshooting while partnering closely with security and infrastructure teams. This is a time-sensitive opportunity with high visibility, ideal for a detail-oriented macOS expert who thrives in enterprise environments and enjoys improving systems and processes.Day-to-Day?Manage and support macOS device fleet using Workspace ONE UEM?Design, deploy, and maintain macOS configurations and environments?Package and deploy applications, scripts, and security updates?Build and support automated enrollment workflows (DEP/ADE)?Monitor OS updates, patching, and device health at scale?Ensure compliance with cybersecurity and patching standards?Provide advanced troubleshooting and remediation for macOS issues?Perform root cause analysis and drive long-term fixes?Partner with stakeholders to gather requirements and improve processes?Create and maintain technical documentation, SOPs, and KB articles?Provide post-deployment and end-user support$45/hr to $55hr.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

Insight Global is seeking an Operations Manager (1st Shift) to support a medical device manufacturing operation in Norwood, MA. This is a full-time, onsite leadership role responsible for overseeing... More first-shift operations across two manufacturing buildings and leading a high-performing operations team.Day-to-Day Responsibilities-Lead and motivate manufacturing teams across two facilities, fostering a culture of accountability, collaboration, and continuous improvement.-Manage daily production output, quality performance, shop floor controls, and task assignments.-Partner with planning, production supervisors, and engineering to manage day-to-day production activities.-Implement and maintain manufacturing process controls and quality standards to ensure compliance with customer, GMP, and ISO 13485 requirements.-Drive strategies to scale manufacturing operations in support of future growth.-Conduct resource planning and proactively identify staffing, equipment, and capability gaps.-Coach, mentor, and develop supervisors, leads, and production associates, including onboarding and performance development.-Establish and lead Lean manufacturing initiatives, including daily standups, Gemba walks, and continuous improvement projects.-Identify and implement process improvements to increase efficiency and reduce costs.-Collaborate with senior leadership and HR on hiring needs, training requirements, and workforce planning.-Ensure compliance with Quality, EHS, and OSHA requirements, policies, and procedures.-Establish departmental goals, track KPIs, manage budgets, and oversee departmental expenses.-Support performance management activities, including feedback, disciplinary actions, promotions, and performance reviews.-Perform other related duties as assigned.Compensation:$140,000 - $150,000 per year (annual salary)Exact compensation may vary based on skills, experience, and education.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 Mechanical Project Development Engineer is responsible for designing and developing complex medical device components by translating engineering requirements into high-quality, compliant design... More solutions with limited supervision. This role defines and executes test and validation activities, resolves advanced technical issues to ensure reliable production, and evaluates external components and technologies to meet quality, performance, and regulatory standards. Key Responsibilities: ? Designs and develops mechanical components and assemblies for medical devices by translating engineering requirements into robust, manufacturable design solutions with minimal supervision.? Troubleshoots and resolves complex mechanical and system-level issues, working cross-functionally to prevent production delays and improve product durability and reliability.? Evaluates and selects mechanical components, materials, and suppliers, ensuring designs meet performance, manufacturability, and cost objectives.? Communicates mechanical design progress and technical findings clearly, supports junior engineers, and applies mechanical engineering best practices to improve processes, product performance, and time to market.? Develops and executes mechanical test plans and validation activities to verify performance, reliability, and compliance with quality and regulatory requirements.Support and execute Corrective and Preventive Actions (CAPA) functions within an R&D product/process scope.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 seeking a Program Operations Specialist for a long-term opportunity in the Irvine, CA area. This Specialist will be tasked with driving adoption and customer experience troubleshooting... More of a new digital surgery platform in the medical device industry. The role will support a U.S.-launched solution with plans for global expansion, focusing on improving onboarding, communication, and operational efficiency across stakeholders. This consultant will act as a central point of coordination between sales representatives, surgeons, executive leadership, and technical partners (software development teams). The consultant will simplify complex information into clear, actionable guidance, support onboarding and contracting processes, and proactively address adoption barriers through high-touch communication and process streamlining. Strong Microsoft Suite background (Teams, Excel, PowerPoint and Outlook) will be critical to hitting the ground running and the ideal candidate will be able to go on site to Irvine, CA two days a week. The current workload has 80 open cases and with global adoption planned to help patients visualize potential outcomes in seconds, this app brings clarity to the decision-making process, supports a more confident, personal choice, and has been shown to help patients feel ready to make decisions more quickly.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

As a Software Test Engineer within our organization, you will play a critical role in verifying software for a groundbreaking robotic surgical platform. This role is highly hands-on and... More domain-driven, requiring deep understanding of complex hardware, embedded systems, and how software interacts with physical devices in a regulated medical environment.This position is ideal for someone with strong manual testing expertise, true medical device or robotics domain knowledge, and experience working at the intersection of hardware, firmware, networking, and software.?Execute manual test cases, test scripts, and formal verification protocols across functional, integration, and system-level testing?Install software on robotic surgical platforms and perform testing on release builds?Perform ad hoc and exploratory testing during development cycles, including defect verification and regression testing?Create, update, and maintain detailed test documentation, scripts, and execution records following formal design verification practices?Work closely with software, firmware, and hardware engineering teams to identify, troubleshoot, and resolve defects?Validate end-to-end workflows involving hardware?software interfacing and device-to-device communication?Support system qualification, instrument qualification, and equivalency testing as required?Use defect tracking and requirements tools to trace coverage and ensure compliance with regulatory expectationsWe 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