Job Search Results for Medical device

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

Insight Global is hiring a proactive and detail-oriented Project Manager to support a Product Engineering organization within a leading medical device company. This role is critical in driving... More compliance, operational excellence, and digital transformation initiatives. You will manage remediation and base business projects, coordinate leadership updates, and ensure timely execution of deliverables.Key Responsibilities (Day-to-Day)-Partner closely with the Engineering Core Team Leader, Engineering Manager, and cross-functional core team members to drive execution across active medical device development projects.-Lead recurring core team meetings, including agenda creation, facilitation, documentation of meeting minutes, and tracking of decisions, risks, actions, and escalations.-Own and maintain the core team communication deck, ensuring responsible functional leads provide timely and accurate pre-meeting updates.-Conduct regular 1:1 check-ins with Engineering, NPI, and Product Management core team leads to maintain alignment, resolve dependencies, and proactively address risks.-Collaborate with Engineering leadership to identify priority discussion topics for core team meetings and define strategies to secure cross-functional alignment and buy-in.-Maintain accountability for the weekly tactical program deck, ensuring inputs are current and distributing finalized updates to the management team by established deadlines.-Compile leadership status update materials, coordinating with functional owners to deliver clear, concise weekly updates to senior stakeholders.-Manage coordination across multiple project and program workstreams, identifying cross-lane impacts and communicating risks or conflicts to Engineering Leads and Engineering Management.-Maintain and update integrated schedules across project and program lanes, ensuring visibility into timelines, milestones, and execution readiness.-Provide short-term execution support during periods of increased project load while also ensuring continuity during planned team transitions, including parental leave coverage.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 supporting Orlando Health's Clinical Engineering team in hiring an entry-level Clinical Engineer Technician. This person will:? Perform routine safety checks, scheduled maintenance... More (SM/PM), calibrations, and repairs on diagnostic and therapeutic medical equipment? Utilize service manuals, documentation, and technical resources to troubleshoot and complete repairs or upgrades. ? Support the integration of medical devices with hospital IT systems and networks.? Enter documentation for all completed work to meet FDA, Joint Commission, and hospital regulatory requirements.? Communicate repair status with Supervisors and clinical departments.? Assist with incoming equipment inspections and support occasional after-hours or on-call needs.Maintain a clean, safe workshop area and uphold Orlando Health policies and HIPAA standards.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 will serve as the primary continuous improvement and manufacturing process lead for a medical device business unit with operations in Santa Clara. The individual will work closely with the... More NPI team developing a new, non commercialized product and will independently lead Gemba walks, capacity analysis, and Lean initiatives. While a support team exists (including international external suppliers), this role will be the main driver of CI conversations and execution.This position requires strong experience in regulated manufacturing environments and the ability to lead cross functional discussions with minimal oversight.?Lead and support Gemba walks, driving actionable outcomes ?Perform capacity analysis for NPI and capital manufacturing processes related to robotic systems ?Support Lean initiatives including: ?5S?Visual management?Value stream mapping?Partner closely with the NPI team prior to commercialization ?Serve as the main CI point of contact, leading discussions independently ?Collaborate with external manufacturing partners to share best practices and improvement ideas ?Support capital manufacturing process development for robotic systems built onsite ?Analyze and present data using Excel and CI tools to support decision making ?Ensure alignment with regulated industry requirements and documentation standardsWe 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 Senior Manufacturing Engineer with a strong focus on manufacturing data collection, pilot execution, and process control to support medical device production in the Blue Ash,... More OH area. This role bridges manufacturing execution with data systems to enable robust process monitoring, capability analysis, and continuous improvement. The ideal candidate excels in pilot build coordination, manufacturing data systems, and translating production data into actionable insights that support compliance, efficiency, and scalability.Core responsibilities will include:-Support New Product Development (NPD) and manufacturing scale-up in compliance with FDA, ISO 13485, and internal quality systems.-Plan and execute engineering and pilot builds, coordinating cross-functionally to transition processes into full production.-Develop and execute process characterization plans to identify and optimize CPPs and CQAs.-Design and execute DOE and statistical analyses; establish process capability metrics (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies using manufacturing data systems.-Lead Measurement System Analysis (MSA) and Gage R&R activities to ensure data integrity and measurement reliability.-Provide hands-on manufacturing support during development, qualification, validation, and production stabilization.-Author and execute protocols and audit-ready completion reports in support of process validation and regulatory inspections.-Support validation and troubleshooting of PLC-controlled manufacturing systems in collaboration with automation and controls 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

Insight Global is seeking an eager and motivated professional to help join a medical device company located in Minnetonka, MN. This resource will be joining a highly collaborative team in one of the... More largest Medical Device companies headquartered in Marlborough, MA. This resource will be working with Sr. Lab Engineers and a Researcher to develop testing methods and executing those methods to complete the vision of the Researcher. This resource will need to be comfortable with being independent, drive tests/studies, and not be afraid to fail.Daily work will be in an R&D environment working on single use as well as capital medical equipment. There will be pockets of sustainability functions, but primarily in an R&D role. This position will be required to be 100% onsite 1st shift. 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 in the Lebanon, TN area is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and rigorous research. Their R&D team... More is seeking a Senior Embedded Software Engineer to architect and deliver reliable, safety critical firmware for connected motor driven medical devices. In this on site Lebanon, TN role, you will design and implement C/C++ firmware on RTOS based microcontrollers, develop secure connectivity (BLE/Wi Fi) and high reliability communications (CAN, SPI/I?C), and lead motor control integrations that balance performance, responsiveness, and patient safety. You?ll collaborate cross functionally with Product Management, Mechanical, Electrical, Quality/Regulatory, and Manufacturing to translate clear requirements into verifiable designs, ensure end to end traceability, and support builds, V&V, submissions, and transfer to production. You will apply IEC 62304 practices and work within ISO 13485 and ISO 14971 to document architecture, risk controls, and evidence for EU MDR & FDA, while continuously improving code quality, tooling, and CI workflows. Successful candidates bring deep embedded expertise, rigorous test and debug skills, and the judgment to ship iteratively while maintaining compliance and reliability for users worldwideEssential Duties and Responsibilities:Responsibilities may include:?Design & implement embedded firmware in C/C++ for microcontroller-based systems leveraging RTOS for deterministic, safety critical operation.?Develop connectivity features (Bluetooth/BLE, Wi Fi) and robust communications (CAN bus, SPI/I?C) for multi-board, multi-sensor systems.?Own motor control firmware: integrate motor drivers/control circuits, implement control loops, and optimize performance, responsiveness, and safety.?Contribute to safety & compliance: apply IEC 62304 software lifecycle practices, support IEC 60601 electrical safety/EMC considerations, ISO 13485 QMS, and ISO 14971 risk management (hazard analysis, risk controls, traceability).?Document and trace requirements, architecture, design, risk controls, verification, and defects in Agile/Jira with end-to-end traceability.?Test rigorously: create unit and integration tests, bring up hardware, perform fault injection, and support verification/validation activities.?Tooling & automation: build developer tooling and scripts in Python; contribute to CI workflows; instrument firmware for diagnostics and telemetry.?Cross-functional collaboration: partner with Electrical, Systems, Quality/Regulatory, Manufacturing, and Field Service to support builds, audits, transfers to production, and post market improvements.?Regulatory support: prepare technical documentation and evidence for UL, FCC, and FDA submissions in collaboration with Regulatory Affairs and Quality.?Continuous improvement: drive code reviews, design reviews, and process improvements to enhance reliability, security, and developer productivity.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 NPD Equipment Engineer with a strong focus on manufacturing data collection, pilot execution, and process control to support medical device production in the Blue Ash, OH area.... More This role bridges manufacturing execution with data systems to enable robust process monitoring, capability analysis, and continuous improvement. The ideal candidate excels in pilot build coordination, manufacturing data systems, and translating production data into actionable insights that support compliance, efficiency, and scalability. Core responsibilities will include:-Support New Product Development (NPD) and manufacturing scale-up in compliance with FDA, ISO 13485, and internal quality systems.-Plan and execute engineering and pilot builds, coordinating cross-functionally to transition processes into full production.-Develop and execute process characterization plans to identify and optimize CPPs and CQAs.-Design and execute DOE and statistical analyses; establish process capability metrics (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies using manufacturing data systems.-Lead Measurement System Analysis (MSA) and Gage R&R activities to ensure data integrity and measurement reliability.-Provide hands-on manufacturing support during development, qualification, validation, and production stabilization.-Author and execute protocols and audit-ready completion reports in support of process validation and regulatory inspections.-Support validation and troubleshooting of PLC-controlled manufacturing systems in collaboration with automation and controls 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

Insight Global's Med Tech Client is looking for a Software Quality Engineer to lead quality activities throughout the SDLC for Software as a Medical Device. This person would be responsible for... More formalizing a validation plan, testing and executing validation strategy, and providing documentation that shows the impact to the product. The Software Engineer will be working across several tools, applications and software to understand what is tied to the product to understand the impact as the company is going through a divestiture. This person should understand the appropriate level of validation needed, understand pass/fail requirements, risk management and have strong problem solving skills. Experience in Cybersecurity would be a plus. The Software Quality Engineer should also be familiar with IEC 62304.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