Job Search Results for medical device regulations

Engineering Operations Project Manager- India

We are seeking a hands-on Technical Project Manager to support Engineering Operations by actively managing and contributing to work across R&D process governance, KPI management and prioritization,... More tool administration and validation, validation automation planning, change control, integration testing coordination, and design validation tracking. This role requires direct execution of tasks in addition to driving work through Scrum/Kanban boards. The ideal candidate is technically fluent, execution-focused, and comfortable operating in regulated R&D environments, with availability for a minimum of two hours overlap with US Eastern Time (EST). Compensation:$8-10/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

Tool Engineer- INDIA

We are looking for a highly skilled Tool Administrator/Engineer. The Tool Administrator for SaMD Product Development Tools is responsible for the configuration, administration, and user support of... More digital platforms used throughout the software development lifecycle (SDLC) of Software as a Medical Device (SaMD). This includes tools such as Jama Connect (Requirements and Test Management), Azure DevOps (Work Item Tracking, Source Control, Build/Release Pipelines), and others as applicable. The role ensures these tools align with regulatory requirements (e.g., FDA, IEC 62304, ISO 13485) and supports system access via Single Sign-On (SSO) integration.Compensation:$13/hr to $16/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st 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.Key Responsibilities:? Tool Administration: Configure and maintain SDLC/ALM tools (e.g., Jama Connect, ADO, Git), manage roles, permissions, templates, and workflows.? Access & Security: Integrate tools with SSO (Azure AD, Okta), enforce secure authentication and access controls.? Compliance & Validation: Support tool validation per ISO 13485 and 21 CFR Part 11, maintain audit-ready documentation and change logs.? User Enablement: Provide tool support, training, and onboarding; handle inquiries and tickets.? Process Integration: Align tools with SaMD processes including risk management, traceability, and design control.? Monitoring & Optimization: Track tool performance, usage, and updates; recommend improvements for usability 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

AI QA Engineer

Insight Global is seeking an AI QA Engineer to join one of our medical device clients local to India. In this role, you will work across Snowflake, AWS, and Azure while partnering closely with AI... More Data Engineers, AI Engineers, and Product teams to develop robust testing frameworks for RAG pipelines, vector stores, OCR workflows, LLM applications, and AI-enabled services. You will design and implement comprehensive QA strategies covering every stage of the AI lifecycle?from data ingestion and preprocessing to embedding creation, vector indexing, retrieval accuracy, model inference, and deployment. This role involves building automated test suites for APIs, data pipelines, and retrieval systems; validating the correctness and performance of vector databases and embedding workflows; and ensuring document-processing systems powered by Azure Document Intelligence, AWS Textract, and similar tools are functioning reliably. You will help integrate automated testing into CI/CD workflows, contribute to the creation of evaluation metrics and monitoring dashboards, and champion QA best practices to elevate our organization?s overall quality maturity. Ultimately, you will play a critical role in ensuring that our AI systems consistently deliver accurate, compliant, and trustworthy outcomes.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

Product Security Engineer- India

We are seeking a Product Security Engineer to work with one of our Large Medical Device Clients. The Product Security Engineering Contractor will assist with product security tasks, deliverables, and... More support for the product security and systems engineering teams. This role requires technical expertise, knowledge of safety critical systems, and the ability to work in a team environment to ensure security and resilience of our current and developing digital products.Responsibilities:? Understand and adhere to Quality Management System requirements? Contribute to the development/maintenance of threat models, product security risk documentation, and other QMS deliverables? Identify and consult on requirements to help address and mitigate security risks and vulnerabilities.? Serve as subject matter expert to the development teams, be security minded and raise the level of understanding and compliance.? Leverage tools like Polaris (Blackduck) to perform and triage SAST, DAST, SCA scans. ? Collaborate with the team on the security testing and security signals ? Support compliance with regulatory requirements, industry standards, and internal policies governing product security.? Stay informed about new tools, regulations, standards, and best practices of the industry.Compensation:$10/hr to $14/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st 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

AI Data Engineer (AWS/Azure)

Insight Global is seeking an AI Data Engineer with deep expertise in AWS or Azure to join one of our medical device clients local to India. In this role, you will develop scalable ETL/ELT pipelines... More to ingest and process large volumes of unstructured data, leveraging cloud-native services such as Azure Document Intelligence, AWS Textract, and other OCR tools to extract and prepare content at scale. You will architect and manage high-quality embedding pipelines, chunking strategies, and vector database integrations?including platforms like Azure AI Search?to support Retrieval-Augmented Generation (RAG) workflows and intelligent search capabilities. You will build retrieval and orchestration pipelines that connect data to LLMs, implement resilient CI/CD workflows, and ensure strong logging, monitoring, and error handling for production reliability. Working closely with platform and application teams, you will integrate LLM-powered features into enterprise applications and deploy services using functions, containers, and event-driven cloud technologies such as AWS Lambda and Azure Functions. A strong focus on security, compliance, scalability, and performance will be critical as you help advance the organization's AI engineering ecosystem.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 Software Engineer- India

We are seeking a Software Engineer with expertise in C#/.NET to design and maintain secure, scalable solutions and integrate healthcare systems using HL7, DICOM, and FHIR standards. Responsibilities... More include writing high-quality code, developing unit tests, creating clear documentation, and mentoring junior developers through code reviews. The role requires strong technical skills, attention to performance and security, and collaboration across teams to deliver reliable, interoperable software.Compensation:$10-15/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

Sr QA Engineer - Design Control

We are seeking a Sr. Quality Engineer - Design Control to lead the design control activities across the IVD product lifecycle, ensuring compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other... More global regulatory requirements. This role will serve as the primary Quality partner to R&D and cross-functional teams, driving robust design control execution, effective risk management, end-to-end traceability, and sustained audit readiness. The ideal candidate will bring hands-on experience leading design control and risk management activities in a regulated IVD environment, including products developed under ISO 13485 and IVDR. Responsibilities:? Serve as the QA lead on cross-functional product development teams, ensuring design control requirements (FDA 21 CFR 820.30, ISO 13485, IVDR) are incorporated from planning through commercialization.? Ensure compliance with all applicable standards, regulations, and internal SOPs throughout the design and development (D&D) process and design changes. Provide guidance on Quality System requirements related to design and development (design history file, design inputs, design outputs, V&V plans and reports, design transfer, device master record etc.) and design changes.? Lead risk management activities for projects under design control, ensuring risk management activities comply with internal procedures, ISO 14971, and applicable regulations. This involves issuing the Risk Management Plan and Risk Management Report, leading cross-functional risk management activities including hazard analysis, risk assessments, and ensuring effective risk control measures, residual risk acceptance, and link risk to design changes and CAPAs. ? Support design verification and validation activities by reviewing protocols and reports to confirm that design outputs meet design input requirements and that analytical and clinical performance is demonstrated. Help resolve any discrepancies through root cause analysis and corrective actions.? Ensure ongoing design control compliance for design and post market changes, maintaining DHF integrity throughout product lifecycle.? Participate in internal and external audits, serving as the SME for design control and risk management, preparing audit responses, and leading remediation activities.? Proactively identify any gaps in compliance and lead CAPA initiatives related to design control or development process issues.? Evaluate and implement process improvements to enhance efficiency, compliance, and scalability as the portfolio grows.? Develop metrics and KPIs related to design control effectiveness 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

Tier 1 Service Desk Analyst (REMOTE) - WEEKEND OVERNIGHT SHIFT

An international law firm spanning across the US/Europe/Asia is looking for Service Desk Analysts to join their fully remote 365, 24x7 Level 1 Service Desk for roughly 3000+ end users. This role is... More primarily a phone support role and focusing on 1st level support, and then each field office has their own Level 2 Desktop techs. The firm is in the Top 50 largest law firms in the world; they focus on corporate, litigation, intellectual property, fund formation, public markets, employment, life sciences (#1 law firm for tech and life sciences IPOs), clean technology, real estate, financial services, retail, regulatory and energy practices. The firm received the following awards form Fortune Magazine: Best Companies to Work For, Best Workplaces for Women, Best Workplaces for Flexibility, Best Workplaces for Giving Back, and Best Workplaces for Parents.The Service Desk analyst will serve as the front line for the firm and will assist the organization in managing processes for Incident, Change, Service Request and Problem Management. The Service Desk Analysts shift vary from day shifts, weekend, swing. We are in current need of shift: SAT-WED 12AM EST (midnight)- 830AM EST. This will be an overnight weekend shift.We are seeking folks who are customer service-oriented, high energy, professional, and eager to learn new technologies. The agents will be handling roughly 400-500 contacts a day (roughly 12-14/hr); roughly 33% of tickets are calls into the Service Desk, and 67% are emails coming in that will be allocated for scheduled calls.Since this is a 365 desk there will be some US holidays that the analysts will need to work on a skeleton crew.Responsibilities:Provide responsive, timely and high-quality support to corporate customers regarding their technical inquiries, driving ownership and resolution of issues through critical thinking, technical proficiency, and excellent communication.- Research, resolve, and respond to complex questions received via emails, chat, and collaboration tools, providing support on the computing and collaboration environment, including the following systems, platforms, or technology:-Microsoft Office 365 Account Support, Password Resets, etc.-Windows 10; PC Laptop, Desktop and Mobile Device support-MS Office Productivity Suite functional support-Collaboration tools including but not limited to Zoom-Remote support toolsets including: ProxyPro-Support of Audio-Visual teleconference systems, equipment, and scheduling, such as Zoom Rooms-Acquire and maintain knowledge of updated supported platforms and releases, current support policies, and methods of support delivery, to provide technically accurate solutions to customers.-Attend structured and unstructured (shadow, OJT) training sessions offered within the group and assist in training workshops, as well as weekly Team training sessions.-Utilize ITSM ticketing system (such as ServiceNow) to classify, prioritize and enter details of each working interaction with appropriate level of detail and attention to completeness, accuracy, and grammar.-Participate in team projects that enhance the quality or efficiency of Service Desk service.-Average handling time ~9-13 minutes, handling 12-14 contacts/hourly.-Accurate troubleshooting notes, multi-tasking - documenting and troubleshooting simultaneouslyCompensation:$25/hr to $27/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

Endpoint Systems Administrator

A local healthcare client is seeking a Systems Administrator to join their IT team. This role serves as the highest technical escalation point for Help Desk and Field IT teams and is responsible for... More supporting a large, multi-OS endpoint environment. The ideal candidate will have strong experience with Windows imaging, endpoint management tools (such as Intune, KACE, Jamf, or similar), automation/scripting, and enterprise desktop support along with excellent communication and problem-solving skills.Compensation:$35-42 per hourExact 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