Job Search Results for medical device regulations

Insight Global is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards... More throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance.DUTIES AND RESPONSIBILITIES:? Lead the design assurance activities and support product development through design verification and validation.? Develop and execute risk management and design control documents, including DHF, DMR, and technical files.? Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.? Analyze testing data and prepare technical documentation for submissions to regulatory bodies.? Oversee design reviews and provide constructive feedback to team members.? Stay updated on industry trends and regulatory changes to continually enhance design assurance 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

The Sr. Manager-Risk Management Process is responsible for managing risk processes throughout the product lifecycle, ensuring compliance with ISO 14971 standards, and collaborating with... More cross-functional teams. This role involves overseeing product quality and process reliability, supporting new product development and validation, and assisting with complaint investigations and resolutions of non-conforming products. The Sr. Manager also handles corrective and preventive actions (CAPA), identifying and solving diverse problems to their root cause, and implementing improvements that support business needs and goals.Additionally, the Sr. Manager manages technical staff to establish functional goals and meet assigned objectives. They are accountable for overseeing activities within the function and working closely with subordinates by providing regular guidance and direction to ensure goals are met or exceeded. The position requires leading by example in alignment with company values to achieve objectives.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 large CPG client of ours is looking for a regulatory coordinator for a 5 month (starting) contract that will be focused on ensuring global product registration and compliance for a cosmetics brand.... More Responsibilities include managing registration guidelines, preparing samples, coordinating formula checks, and maintaining product dossiers and labels in line with international regulations. The position involves advising headquarters on U.S. labeling laws, overseeing updates like MoCRA and annual reports, and collaborating with consultants and internal teams. It also includes maintaining the Product Information File (PIF), tracking regulatory changes, and supporting global expansion efforts through product registration, relaunch approvals, and set/sample coordination.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 a Senior Network Engineer at Langley AFB, VA. The Senior Network Engineer performs the configuration, integration, and upgrade of all network architectural components.... More Their responsibilities include, but are not limited to: -Tier 3 Network Infrastructure Management -Establish system performance parameters and sample critical network and information processing -Conduct network trend analysis and create reports and graphs monthly -Sort and file network traffic based on source and destination internet protocol (IP) addresses as needed -Establish baseline network configuration and performance parameters in support of unique ISR sensor data -Conduct network analysis to ensure performance of the network -Support design, installation, and integration of new routers and other equipment on the enterprise -Establish proper data flows between DCGS and other Enterprise nodes -Maintain network interface/port configurations, IP routing tables, firewall settings, filter tables, passwords, and performance controls -Maintain version control of the router operating system software at Government direction -Establish configuration and modification of device settings protecting the DCGS Security Boundary through Access Control Lists -Manage and operate software applications at all sites required to conduct network management of the DPA -Respond to hardware and software problems related to DPA equipment -Coordinate with Government leads to optimize Campus Area Network (CAN) routers, switches, and cryptographic devices -Install CAN/WAN equipment and develop and maintain documentation and drawings -Develop and enforce a comply-to-connect standard for the DPA -Review all integration efforts to ensure engineering rigor and security practices are maintained across the DPA and advise Government leadership regarding any possible risks/concerns/improvements -Process and implement all network service request?s (NSR) and security approved ports and services requests (PSR) -Perform transition planning, integration, operations and maintenance (O&M) of ATM to Carrier Ethernet/OTN, to include out-of-band network management -Develop and execute OTN test plan and procedures Compensation:$55/hr to $63/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

A top personal care company is seeking a R+D Scientist who will participate in cross-functional meetings to develop and support various projects, coordinate and design studies to support product... More claims, and ensure all product claims comply with global regulations. Candidate will review product artwork to ensure communication matches data, analyze study results to brainstorm communication strategies, and listen to consumer data focus groups to gather insights. The specialist will also conduct update meetings to ensure team alignment and write defensives about product claims.Preferred candidates will have the ability to assess risk based on technical data and navigate gray areas, strong computer skills including proficiency in Word, Excel, and PowerPoint, excellent communication skills, and the ability to work effectively in a team and matrix environment. The day-to-day activities for this role will vary, including participating in cross-functional meetings, coordinating studies, reviewing artwork, analyzing study results, listening to consumer focus groups, designing studies, conducting update meetings, and writing defensives about claims.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. 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 Systems /Reliability Engineer will manage the verification and traceability of product requirements and specifications for new hardware and software products, aid in product validation planning... More and execution, and analyze/calculate/report on reliability and durability verification activities. The expectation for a Senior Systems / Reliability Engineer is that they regularly serve on the systems engineering team and interact with electrical, mechanical, and firmware engineers to achieve verification goals, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such, they are expected to help identify tasks/resources and fulfill them to ensure that critical project milestones are met and systems integration activities are completed, including reliability testing and statistical data analysis.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

Critical Environment Culture ?Understands, follows, and ensures safety and security requirements (e.g., job hazard assessments [JHAs], toolbox talks), and business processes and procedures are met,... More to properly perform work in a safe, quality, and reliable manner in accordance to applicable Authority Having Jurisdiction (AHJ) regulations, and [clients] requirements. ?Recognizes safe versus unsafe working conditions and responds accordingly (e.g., stop/pause tasks, stand down vendors where necessary). Escalates immediately when unsafe working conditions are observed and promotes a safe working culture to empower other team members. Participates in required meetings, trainings, and necessary handoffs. Equipment and Systems Maintenance ?Processes method statement of work (MSOW) documents. Coordinates activities and associated schedules with contractors. Performs inspections of equipment in a facility. Participates in testing and commissioning activities. Advises engineer partners or project management colleagues on project scope process or execution methodology. Presents for review and approval MSOW in their area of responsibility. ?Prepares and submits reports as assigned following preexisting scripts and templates, or using ad hoc methods required to support trending and analysis (e.g., Root Cause Analysis [RCA] reports) and may review prior reports delivered by less experienced team members. ?Performs various types of maintenance (e.g., planned, predictive, corrective) and repairs for multiple disciplines and multiple equipment types of increasing complexity with no supervision, while serving as a subject matter expert for one discipline - in consideration of Task Hazard Analysis (THA), Method Statement of Work (MSOW), or varying permit requirements. Communicates and/or escalates maintenance activities per established process and procedure. Prioritizes maintenance activities as required and/or appropriate. Documents tasks or issues during maintenance activities within appropriate systems per process and procedure as needed. Provides consultation to colleagues on maintenance and repairs through deep understanding of equipment, systems and their interrelations. Follows recommended maintenance schedules. Oversees everyday, complex, large-scale tasks for a single discipline or equipment across disciplines. ?Performs troubleshooting independently for multiple equipment, systems, subsystems, and component types. Documents issues found in troubleshooting process within appropriate systems per process and procedure as needed. Ensures equipment and system settings are consistent with established parameters and designs. Determines when troubleshooting efforts are deemed adequate and communicates or escalates to suppliers, engineers, or more experienced colleagues as needed. ?Provides necessary escort to third-party contractors, sub-contractors, vendors, and service providers on site based on all procedure levels of risk (LOR). Equipment and Systems Operations ?Safety and quickly responds to and leads an onsite incident response team for all abnormal conditions that impact operations, and coordinates with other critical facilities professionals to perform corrective repairs, without supervision. Gathers necessary information and creates incident timelines/data, root-cause analyses, and/or action items following an abnormal condition as required. Identifies and contacts/engages appropriate parties to mitigate incidents as they occur. Develops new or follows preexisting emergency operating procedures (EOPs), methods of procedure (MOPs), standard operating procedures (SOPs), and digital methods of operating procedures (DMOPs) in relation to incidents. ?Completes the inspection and supervision of critical environment-related facility equipment (e.g., controls, heating, ventilation, and air conditioning [HVAC], mechanical systems), building, and grounds for unsafe or abnormal conditions. Understands critical system alarms for multiple discipline(s) of equipment, their meanings, and engages with appropriate escalation processes or procedures. Recognizes circumstances where execution would be considered safe to proceed. Performs various inspections and validations of equipment performance. ?Works on critical operational tasks (e.g., stabilization, resolution, recovery) independently. Serves as a subject matter expert in select critical environments-related systems within the data center commensurate with their training and work experience, advises less experienced colleagues on such topics, and provides oversight and training/mentorship to team members on tasks regarding these subsystems (e.g., electrical, mechanical, controls, generators). Physical Requirements ?Occasional climbing of ladders. Frequent climbing of stairs and/or ramps. Prolonged standing. Occasional lifting 50lbs / 22.5kg. Occasional push or pull 50-75 lbs / 22.5-34kg. with assistive device. ?Normal visual acuity (near, far and peripheral with correction), defined via standard medical terms and applicable criteria. Normal color vision for electrical work, defined via standard medical terms and applicable criteria. Working Conditions ?Working for extended periods under elevated levels of ambient noise, heat, and light due to necessary equipment and ventilation systems.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 a Linux Engineering Tech Lead to join one of our federal clients in Virginia Beach, VA. The Linux Engineer will support live, virtual, and constructive training... More events. They will also provide technical leadership in the planning and execution of these training events if they have lead experience. In this role, the technical lead collaborates with the operational event lead for the training event mission requirements and liaisons with the entire engineering department to ensure these event requirements are met. They will be responsible for troubleshooting any systems issues at these training events to ensure the training event system interfaced are configured and deployed in accordance with documented interface standards. This candidate will also deploy and configure software components across the enterprise and perform other engineering projects activities to sustain LVC products and integrate their capabilities into their homegrown training systems.Compensation: $40/hr to 45/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start day 1 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

Insight Global is looking to hire a Tooling engineer for design support for tooling fixtures, gages, and sub-assemblies; may also include market analysis and technician cost modeling. Day to day... More responsibilities include: Design and develop tooling fixtures, gages, and sub-assemblies to support manufacturing and robotic equipment integrationCreate and revise CADD models using NX, applying GD&T principles and performing stack-up analysis to ensure design accuracy and manufacturabilityRedline and check engineering drawings for compliance, clarity, and completenessCollaborate with cross-functional teams?including engineering, production, and calibration?to align tooling designs with operational needsTranslate conceptual designs into practical, real-world solutions that support production efficiency and quality standardsApply GxP standards throughout the design and documentation processSupport market analysis and technician cost modeling as needed for tooling-related projectsParticipate in design reviews and provide technical input on tooling feasibility and implementationCompensation for this role ranges from $55 to $70/HR depending on skillset, education and experience.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

A client of Insight Global is seeking a Secret-cleared Key Management Specialist to sit onsite in Aberdeen, MD. This individual will be responsible for leading and executing the testing and... More evaluation of current and emerging COMSEC devices and technologies, including tactical radios, network encryptors, and key fill devices such as SKLs. The role involves developing and refining test plans, procedures, and use cases for key management systems, and working closely with a team of 6?7 peers focused on testing, documentation, and stakeholder engagement. The specialist will operate within a lab environment to validate new technologies and troubleshoot systems, while also preparing and delivering technical documentation (Word, PowerPoint) including KCMPs and standards. Additionally, the role requires engaging with vendors and DoD stakeholders, presenting findings to senior leadership, and participating in Army, DoD, and NSA Key Management Working Groups$45/hr to $75/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