Job Search Results for medical device regulations

An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term... More and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R&R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R&D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking a Manufacturing / Validation Engineer to support a top medical device manufacturing client in Raynham, MA. This individual will play a critical role in the launch of a new... More production line, supporting the installation, commissioning, and qualification of new manufacturing equipment. The engineer will work cross-functionally with Quality, Commissioning, and Operations teams to ensure equipment meets regulatory and internal standards and is fully production-ready. This is a hands-on, high-impact role ideal for someone who thrives in fast-paced, highly regulated environments and enjoys bringing new manufacturing capabilities online.Compensation: $45/hr to $48/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking a detail-oriented Tester/Systems Analyst?to join the Global Clinical IT team for one of our medical device clients. This role requires a detail-oriented Tester / Systems... More Analyst?to join the Global Clinical IT team supporting a leading medical device client. This role focuses on mapping clinical trial data from source systems to target platforms, defining transformation rules to align data with the target data model, and validating data accuracy through comprehensive testing. The ideal candidate brings strong experience working with Oracle databases, Tableau reporting, and end-to-end data pipelines?(including ingestion, transformation, monitoring, and validation). This position is heavily focused on data mapping and testing, with minimal involvement in requirements gathering.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

An employer is seeking a Program Operations Specialist for a long-term opportunity in the Irvine, CA area. This Specialist will be tasked with driving adoption and customer experience troubleshooting... More of a new digital surgery platform in the medical device industry. The role will support a U.S.-launched solution with plans for global expansion, focusing on improving onboarding, communication, and operational efficiency across stakeholders. This consultant will act as a central point of coordination between sales representatives, surgeons, executive leadership, and technical partners (software development teams). The consultant will simplify complex information into clear, actionable guidance, support onboarding and contracting processes, and proactively address adoption barriers through high-touch communication and process streamlining. Strong Microsoft Suite background (Teams, Excel, PowerPoint and Outlook) will be critical to hitting the ground running and the ideal candidate will be able to go on site to Irvine, CA two days a week. The current workload has 80 open cases and with global adoption planned to help patients visualize potential outcomes in seconds, this app brings clarity to the decision-making process, supports a more confident, personal choice, and has been shown to help patients feel ready to make decisions more quickly.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking an Operations Manager (1st Shift) to support a medical device manufacturing operation in Norwood, MA. This is a full-time, onsite leadership role responsible for overseeing... More first-shift operations across two manufacturing buildings and leading a high-performing operations team.Day-to-Day Responsibilities-Lead and motivate manufacturing teams across two facilities, fostering a culture of accountability, collaboration, and continuous improvement.-Manage daily production output, quality performance, shop floor controls, and task assignments.-Partner with planning, production supervisors, and engineering to manage day-to-day production activities.-Implement and maintain manufacturing process controls and quality standards to ensure compliance with customer, GMP, and ISO 13485 requirements.-Drive strategies to scale manufacturing operations in support of future growth.-Conduct resource planning and proactively identify staffing, equipment, and capability gaps.-Coach, mentor, and develop supervisors, leads, and production associates, including onboarding and performance development.-Establish and lead Lean manufacturing initiatives, including daily standups, Gemba walks, and continuous improvement projects.-Identify and implement process improvements to increase efficiency and reduce costs.-Collaborate with senior leadership and HR on hiring needs, training requirements, and workforce planning.-Ensure compliance with Quality, EHS, and OSHA requirements, policies, and procedures.-Establish departmental goals, track KPIs, manage budgets, and oversee departmental expenses.-Support performance management activities, including feedback, disciplinary actions, promotions, and performance reviews.-Perform other related duties as assigned.Compensation:$140,000 - $150,000 per year (annual salary)Exact compensation may vary based on skills, experience, and education.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking a Mechanical Test Engineer for a top medical device client. This engineer will support verification efforts for a syringe-delivered gel product focused on female urinary... More incontinence. The role involves adapting and developing mechanical test methods, validating test procedures, training technicians, and analyzing mechanical performance data. The ideal candidate is highly hands-on with mechanical testing equipment, comfortable working in a regulated environment, and capable of producing strong technical documentation. This engineer will collaborate cross-functionally to ensure complete verification coverage and maintain high-quality test method traceability.Day-to-Day:Review and adapt existing Boston Scientific test methods for new componentsDevelop, modify, and document procedures for mechanical testing (volume displacement, tensile, torque, etc.)Lead test method validation and train/coach techniciansCoordinate technician scheduling and manage daily test execution activitiesPerform statistical data analysis in Minitab and prepare test reportsOperate and specify mechanical test equipment (MTS systems, torque gauges)Partner with chemical/test engineers to ensure complete verification coverageMaintain documentation, data files, and test traceabilityEnsure alignment with quality processes and escalate technical judgment calls when appropriateWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking a qualified QC Chemist to join an established medical device company in Mundelein, IL. This individual will be responsible for conducting chemical analysis on raw materials,... More finished products, and stability samples. Duties include assay, quantification of materials, documentation of results, and general laboratory housekeeping.Responsibilities: Conduct chemical analysis on raw materials, finished goods, stability, and R&D samples.Follow all procedures related to data documentation, laboratory safety, and good laboratory practices.Review test data, calculations, and results for accuracy and completeness.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking an experienced, highly skilled Sr Quality Engineer to support an established medical supply client out of Redmond, OR. Key Responsibilities:Develop and implement procedures... More for QMS, process control, validation, improvement, testing, and inspection.Partner with suppliers to resolve quality issues, ensuring corrective actions (CAPA, SCAR) are implemented.Provide Quality expertise in Product Development, Design Control, Risk Management, Validation, and QMS processes.Build and maintain Device Master Records (DMRs) in compliance with regulations.Collaborate with Regulatory Groups and internal departments to support 510K submissions and related documentation.Ensure compliance with domestic and international regulations.Perform quality reviews of design documentation, validation documentation, and company quality records.Lead investigations of product/process non-conformances and out-of-specification results.Develop and implement effective corrective and preventive actions.Train and mentor team members and employees on quality processes and best practices.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

This role is responsible for executing validation and quality activities required for the introduction and delivery of a new Hinge cast product line, as well as supporting EU MDR validation... More assessment and rationalization. The position operates in a highly regulated medical device manufacturing environment and requires strong expertise in process validation, quality systems, and change control. The successful candidate is a proactive self-starter who collaborates effectively across cross-functional teams to ensure compliance with global regulatory requirements.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking a macOS Endpoint Engineer (Workspace ONE) for a large, enterprise environment. This highly hands-on role will focus on designing, managing, and optimizing macOS device... More management at scale using Workspace ONE UEM. The engineer will play a key role in automation, security compliance, device lifecycle management, and advanced troubleshooting while partnering closely with security and infrastructure teams. This is a time-sensitive opportunity with high visibility, ideal for a detail-oriented macOS expert who thrives in enterprise environments and enjoys improving systems and processes.Day-to-Day?Manage and support macOS device fleet using Workspace ONE UEM?Design, deploy, and maintain macOS configurations and environments?Package and deploy applications, scripts, and security updates?Build and support automated enrollment workflows (DEP/ADE)?Monitor OS updates, patching, and device health at scale?Ensure compliance with cybersecurity and patching standards?Provide advanced troubleshooting and remediation for macOS issues?Perform root cause analysis and drive long-term fixes?Partner with stakeholders to gather requirements and improve processes?Create and maintain technical documentation, SOPs, and KB articles?Provide post-deployment and end-user support$45/hr to $55hr.Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less