Job Search Results for medical device regulations

- 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

Insight Global is looking for a Project Manager in St. Petersburg, FL. This person will be responsible to begin with for internal projects before moving into a client facing Project Management role.... More This is focused on New Product Development for electro-mechanical medical 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

?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

Insight Global is seeking an experienced copywriter to join our client's in-house creative team supporting healthcare providers, patients, and a field sales organization. This role will focus on... More developing clear, compelling, and compliant content across a mix of digital and print materials, including marketing collateral, presentations, ads, emails, websites, conference materials, and video scripts.The ideal candidate has strong experience writing for medical device or healthcare audiences, can confidently adapt tone by audience (patients vs. clinicians), and is comfortable working in regulated environments with cross-functional teams.Responsibilities: - The Copywriter will concept, write, edit, and refine content to support business objectives and strengthen our brand voice.- Work closely with content strategists, designers, marketers, and subject-matter experts to develop compelling digital and print materials.- Write clear, persuasive, and engaging copy for a variety of formats- including ads, email campaigns, web pages, video scripts, presentations, brochures, training materials, and other communications.- Ensure all copy adheres to our established brand guidelines, tone-of-voice standards, and marketing objectives.- Adapt tone and depth based on audience type, channel, and intent while maintaining credibility- Use correct medical terminology and disease-state language when developing content for clinician audiences- Collaborate with vendors, freelancers, and cross-functional partners as needed to produce resources.- Work closely with content reviewers to ensure accuracy and regulatory compliance- Proofread and quality-check deliverables: Serve as the lead for proofreading to catch issues the broader team may miss, ensuring copy is accurate, consistent, and publication-ready.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/.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 hiring a Senior Software Design Verification Engineer (Cybersecurity) for one of our Medical Device clients to lead verification and validation (V&V) activities for embedded medical... More device software, with a strong focus on cybersecurity testing. The role is a mix of hands-on testing (~40%) and strategy/planning (~60%), requiring someone who can thrive in a fast-paced, evolving environment and pivot quickly.Key Responsibilities- Perform software design verification and cybersecurity testing on embedded medical device software.- Develop and maintain V&V processes, procedures, test plans, and project schedules (including regression planning).- Execute cybersecurity testing activities: penetration testing, malformed input/fuzz testing, SAST, SBOM generation/monitoring, threat modeling, and vulnerability assessments.- Build and maintain automated test scripts/tools to streamline embedded software testing.- Lead test-related meetings (Test Approach, Test Readiness, Pre-Release Review) and coordinate with cross-functional project teams.- Produce clear documentation aligned with Solventum procedures and regulatory requirements.- Mentor and train junior verification engineers and test technicians.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 looking for an Electrical Engineer to join a leading medical device manufacturing company in Southern California. This person should have their Bachelor's degree in Electrical... More Engineering or related field, implantable medical device experience and testing experience. This role is responsible for supporting project goals by providing input on progress and recommending adjustments as needed, while clearly communicating risks, trade-offs, and updates to project leadership. The position involves completing complex or novel engineering assignments, including developing new or improved techniques that drive effective integration of medical device technologies into the Boston Scientific portfolio. Key responsibilities include electrical design remediation, product design refinement, specification development, test method validation, and report preparation, along with evaluating the feasibility of alternative engineering processes and solutions. The role also contributes to design hazard analysis and FMEA, ensuring adherence to design control and risk management procedures. Additionally, the engineer produces clear, concise documentation to enable knowledge transfer and collaborates with external partners and suppliers to align on component specifications, qualification and acceptance criteria, testing protocols, and quality standards. This role will be responsible for traveling up to 10%.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

We are seeking a events/marketing professional to work onsite (2-3 days per week) for a large medical technology company based in Irvine, CA. This role is a contract position with the possibility of... More becoming a full time role after a year. This role will be under the marketing team for a specific medical device product line. This role will require about 10% of travel at specific events and including overnight stays and some weekends. The travel for this role will be all throughout the US. In this position you will be supporting two groups - digital marketing and events, where most of the time will be spent helping with logistics for customers attending the internal events (travel, updates, etc.) and the other percent of time will be spent assisting with the digital marketing team. We are looking for someone who is client/customer focused and extremely detail oriented. This person will be responsible for helping with the event trade shows and coordinating travel for 30+ medical professionals.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 Senior Software DQA Engineer supports risk-based design assurance for medical device software, partnering closely with R&D to ensure products are safe, compliant, and aligned with regulatory... More standards throughout development. This is not a hands-on coding or testing role, but rather focused on reviewing software, system design, and documentation to identify risks (especially cybersecurity) and drive mitigation strategies. The role sits in a ?gray area? between software, quality, and cybersecurity, helping ensure software meets requirements across complex systems (software, hardware, firmware).Day-to-day responsibilities include:Reviewing software, code, and system design to identify risks, bugs, and cybersecurity vulnerabilitiesPartnering with R&D to ensure software is compliant and built correctly throughout the SDLCSupporting design reviews, test strategy discussions (unit, regression, automation), and system-level validationIdentifying and tracking risks (DFMEA, hazard analysis, security risk assessments) and driving mitigationEnsuring documentation aligns with regulatory standards and supporting audit readinessTroubleshooting issues and driving root cause analysis for quality concernsHelping define software safety levels and requirements for regulated productsCompensation: $60/hr to $68/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