Job Search Results for medical device regulations

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

Software Engineer

A global leader in the medical technology and life sciences industry is seeking a Software Engineer to develop and enhance core software services that power connected medical devices and digital... More health platforms. This role will focus on building and modernizing cloud-based applications, developing APIs, and enabling secure communication between devices and the cloud. The engineer will work in a cross-functional team environment, contributing to software development, design, and deployment within a regulated industry. The ideal candidate brings hands-on experience with modern cloud technologies (AWS/Azure), a strong grasp of software engineering best practices, and a collaborative mindset for working in global Agile teams.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

UI Developer (IND)

Insight Global is seeking a UI Developer local to India to join one of our medical device clients. We are seeking a skilled UI Developer to design and optimize user interfaces for web and mobile... More applications. In this role, you?ll collaborate with UX designers, product managers, and backend engineers to build responsive, accessible, and high-performing UI components using modern frameworks like React, Angular, or Vue. Responsibilities include ensuring cross-platform compatibility, improving speed and accessibility, implementing CI/CD pipelines and automated testing, and staying current with UI/UX trends. You?ll also troubleshoot performance issues and contribute to a seamless user experience across devices.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

Staff Android Engineer

A leading medical technology company is seeking a Staff Android Engineer to lead the design, development, and delivery of patient-facing mobile applications that connect users to life-changing... More medical devices. In this role, you?ll architect and build complex Android solutions using Kotlin, Java, and Kotlin Multiplatform (KMM)?driving feature development across Bluetooth device connectivity, cloud data workflows, and real-time health management tools. You?ll take full ownership of technical direction, guiding system design, architecture, and performance optimization across a large-scale Android codebase. As a true staff-level engineer, you?ll mentor and develop junior engineers, review code, and influence best practices to ensure scalable, maintainable, and secure mobile solutions. This role is ideal for someone who brings deep Android expertise, thrives in complex environments, and has a proven track record of delivering high-quality, consumer-grade apps.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/DevOps Engineer- India

We are looking for a Software/DevOps Engineer to design and implement Azure DevOps pipelines, automate build and deployment processes, and ensure compliance with security and industry standards. This... More role involves collaborating with development and security teams, creating and maintaining scripts and tools for automation, driving best practices for CI/CD, and supporting agile delivery across multiple scrum teams. Strong communication skills and the ability to guide teams through testing and deployment are essential.Compensation:$12-17/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

CSV Engineer (R - 1 - INDIA)

Insight Global is hiring for a CSV Engineer for our medical device client in Danvers, MA. This position sits remotely in India. We are seeking a Computer System Validation (CSV) Engineer to ensure... More that all computer systems and software applications comply with industry standards and regulatory requirements. This role involves collaborating with cross-functional teams, executing validation activities, maintaining documentation, and supporting compliance initiatives.Key Responsibilities:-Develop and execute remediation activities for CSV processes to assess, plan, and enhance validation practices.-Create and implement validation plans for new and existing GxP computer systems and digital solutions.-Lead and/or support SDLC and Software V&V activities, including requirements analysis, validation planning, testing, qualification, and related deliverables.-Prepare and maintain validation documentation such as test protocols, reports, and risk/compliance assessments.-Conduct assessments and periodic reviews of validated systems to ensure ongoing compliance with regulatory standards.-Provide subject matter expertise (SME) in CSV to system owners and users.Collaborate with QA team members to support quality improvement initiatives.Compensation: $23/hr to $30/hr. Exact compensation may vary based on several factors, including 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

Document Control Specialist (B - 1 - US)

Insight Global Johnson is seeking a Document Control Specialist to join the Document Control team. This role will report to the Document Control Supervisor and play a key part in managing change... More reports, document remediation, and supporting engineering teams with documentation updates.Key ResponsibilitiesChange Control Management:-Process and manage change requests in SAP.-Support migration activities from SAP to Windchill.-Assist in planning and execution of change control projects.Document Control & Remediation:-Review and revise a large volume of documents as part of periodic review processes.-Collaborate with engineering teams to fill documentation gaps.-Act as a technical writer to assist with document revisions and ensure compliance.-Partner with the technical writing team to maintain document accuracy across multiple shifts/sites.System Expertise & Adaptability:-Utilize SAP for change control processes; Windchill experience is a plus.-Quickly learn new PLM systems using available resources (e.g., FAQs, cheat sheets, online tutorials).-Contribute to system design and instruction creation as needed.Project Support:-Participate in planning and prioritization of document updates.-Ensure timely completion of document revisions for key product lines.Compensation: $25.00/hr to $30.00/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

CSV Engineer (B - 1 - INDIA)

Insight Global is hiring for a CSV Engineer for our medical device client in Danvers, MA. This position sits remotely in India. We are seeking a Computer System Validation (CSV) Engineer to ensure... More that all computer systems and software applications comply with industry standards and regulatory requirements. This role involves collaborating with cross-functional teams, executing validation activities, maintaining documentation, and supporting compliance initiatives.Key Responsibilities:-Develop and execute remediation activities for CSV processes to assess, plan, and enhance validation practices.-Create and implement validation plans for new and existing GxP computer systems and digital solutions.-Lead and/or support SDLC and Software V&V activities, including requirements analysis, validation planning, testing, qualification, and related deliverables.-Prepare and maintain validation documentation such as test protocols, reports, and risk/compliance assessments.-Conduct assessments and periodic reviews of validated systems to ensure ongoing compliance with regulatory standards.-Provide subject matter expertise (SME) in CSV to system owners and users.Collaborate with QA team members to support quality improvement initiatives.Compensation: $23/hr to $30/hr. Exact compensation may vary based on several factors, including 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

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

Change Control Specialist

Insight Global Johnson is seeking a Change Control Specialist to join the Document Control team. This role will report to the Document Control Supervisor and play a key part in managing change... More reports, document remediation, and supporting engineering teams with documentation updates.Key ResponsibilitiesChange Control Management:-Process and manage change requests in SAP.-Support migration activities from SAP to Windchill.-Assist in planning and execution of change control projects.Document Control & Remediation:-Review and revise a large volume of documents as part of periodic review processes.-Collaborate with engineering teams to fill documentation gaps.-Act as a technical writer to assist with document revisions and ensure compliance.-Partner with the technical writing team to maintain document accuracy across multiple shifts/sites.System Expertise & Adaptability:-Utilize SAP for change control processes; Windchill experience is a plus.-Quickly learn new PLM systems using available resources (e.g., FAQs, cheat sheets, online tutorials).-Contribute to system design and instruction creation as needed.Project Support:-Participate in planning and prioritization of document updates.-Ensure timely completion of document revisions for key product lines.Compensation: $25.00/hr to $30.00/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