Job Search Results for medical device regulations

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

One of our large Medical Device companies is seeking a Validation Engineer to lead and support cross-functional validation and implementation activities to qualify raw materials, processes,... More equipment, and systems, ensuring timely execution and compliant documentation. Their responsibilities will include: ? Plan and execute multiple validation and implementation projects across manufacturing platforms, from strategy through final report approval.? Develop and qualify material, equipment, and process changes by authoring and executing protocols (IQ/OQ/PQ) and documenting results against acceptance criteria.? Apply structured problem-solving (e.g., RCA/5-Why/FMEA) to investigate issues, define corrective actions, and prevent recurrence during validation and routine operations.? Drive project management for qualification activities, including schedules, risk/issue tracking, stakeholder updates, and readiness for approval.? Identify and implement improvements to manufacturing equipment, processes, and systems based on data analysis, investigations, and validation outcomes.? Own validation documentation deliverables, including plans, protocols, executed test records, deviation investigations, final reports, and change control submissions per the quality system.? Troubleshoot unplanned downtime or excessive rejects during protocol execution by coordinating containment, documenting deviations, and defining re-test or recovery plans to complete validations.? Prepare technical justifications for capital and expense requests, including scope, risk, benefits, and implementation/validation approachWe 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

Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms). Develop V&V test plans, test procedures, and test reports. Review requirements and scrutinize... More for testability. Quickly learn to use automated test tools and specialty test equipment; develop and validate automated test scripts. Execute test procedures both personally and using test technicians. Log defects and issues found during V&V activities and track to closure. Perform regression analysis and determine testing associated with design changes. Provide weekly project status reports. Prioritize project tasks to complete on schedule while maintaining quality of work. Work in a team environment; peer review work. Work on multiple, concurrent projects. You are a part of: Our group works closely with the development team throughout the product development process. We play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase. While having our own responsibilities within the group, we look to each other?s strengths for support in doing our jobs.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/employer of Insight Global is searching for an Environmental Health & Safety (EHS) Coordinator to support their team in Memphis, TN. This role is responsible for supporting and maintaining... More environmental, health, and safety programs to ensure compliance with federal, state, and local regulations. This role partners closely with operations, quality, facilities, and leadership to promote a proactive safety culture and minimize risk to employees and the environment.Responsibilities:-Support the implementation, maintenance, and continuous improvement of EHS programs in accordance with OSHA, EPA, and applicable local regulations. -Conduct routine safety inspections, audits, and risk assessments; document findings and track corrective actions to completion.-Assist with incident reporting, investigation, and root cause analysis for injuries, near misses, and environmental events.-Coordinate and deliver EHS training, including new hire safety orientation, annual refresher training, and job specific safety programs. -Maintain safety documentation, training records, SDS databases, and regulatory compliance logs.-Support environmental compliance efforts, including waste management, hazardous materials handling, and sustainability initiatives. -Participate in emergency preparedness planning, drills, and response coordination.-Partner with cross functional teams to promote a strong safety culture and ensure EHS considerations are integrated into daily operations.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 Senior iOS Developer to join a globally distributed mobile engineering team supporting a medical device mobile application. This role is heavily hands-on while also providing... More technical leadership and mentorship to junior engineers across multiple locations.You?ll work on a native iOS application used to control Bluetooth-enabled hearing aids and provide health-related features such as fall detection, activity tracking, and device configuration.Key ResponsibilitiesDesign and develop native iOS applications using SwiftBreak down complex product requirements into clear, executable technical solutionsGuide and mentor junior and mid-level engineers (approximately 30?40% of the role)Collaborate daily with offshore development teams (India, China, Israel)Participate in design discussions, code reviews, and architectural decisionsWork closely with product, verification, and hardware teamsBuild stable, regulated software within a medical device environment (quality, documentation, review-heavy process)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.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 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

The Urology R&D organization is seeking a highly skilled and motivated Electrical Engineer, with a focus in Test Method Validation to support an acquisition and integration project for a duration of... More 9 months, with the option to extend.In this role, you will be responsible for creating, validating, and documenting test methods for electrical and medical electrical equipment, ensuring compliance with work instructions, SOPs, and applicable standards. A major focus of this position is test method development and validation, including the creation of approximately 60 test method protocols, execution or oversight of validation activities, and preparation of final technical reports. This role will assess acquired company test methods to determine validation needs, perform or coordinate validation testing (e.g., Gauge R&R), and update documentation to justify when validation testing is not required. You will also support technician scheduling and training, perform statistical data analysis using Minitab, and generate final validation and engineering reports.As a key team member, you will provide technical testing solutions and engineering support under guidance from subject matter experts, applying your background in electrical/systems engineering, test method design, test method validation, verification testing, and statistical analysis.Test Method Development & Validation-Develop, write, and maintain test method protocols, with an expected workload of approximately 60 test method protocols during the project.-Create new test methods and improve existing methods for electrical and medical electrical equipment.-Perform and/or oversee test method validation activities, including Gauge R&R and other statistical validation techniques, to ensure compliance with Boston Scientific standards.-Assess acquired company test methods to determine whether validation is required and either execute appropriate validation testing, or update technical documentation with a sound engineering rationale when validation is not required.-Identify gaps in test method validation compliance and define strategies to close those gaps.Testing Execution & Technical Support-Provide hands-on technical support for verification and validation testing activities.-Assess feasibility and soundness of alternative test methods, engineering processes, products, or equipment.-Complete complex or novel assignments requiring the development of new or improved testing techniques and procedures.-Support efficient and effective integration of acquired medical device technologies into the Boston Scientific portfolio.Technician Coordination & Training-Assist with scheduling test technicians to support validation and verification activities.Ensure technicians are properly trained on test methods, protocols, and procedures.Provide technical guidance to technicians during test execution.Data Analysis & Reporting-Perform statistical data analysis using Minitab, including Gauge R&R and process capability studies.-Analyze test results, draw conclusions, and make engineering recommendations based on data from multiple sources.-Write clear, concise final reports, including test method validation reports and technical summaries.Complete high-quality engineering documentation in accordance with Boston Scientific quality systems.Communication & Project Support-Provide input to project goals, timelines, and progress.-Communicate technical progress, risks, and trade-offs to project leadership.-Recommend revisions to testing strategies, documentation, or plans as needed.-Demonstrate strong knowledge of Technology Development and Product Development systems through delivery of high-impact deliverables.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 Director of Downstream Marketing for one of our Medical Device clients for a direct hire opportunity. This person is expected to come onsite 4x/week in Versailles OH. This... More individual will be responsible for executing the business unit strategy through the creation and use of marketing strategies and commercialization plans. The marketing director oversees the creation and execution of the marketing strategy through co-leadership of the business unit through close collaboration with cross-functional peers. Reports to the Vice President of Marketing.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 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

An employer in the Cincinnati, OH area is seeking a Equipment Development Engineer for a long-term opportunity. This Equipment Development engineer will support a project focused on a handheld... More commercial product launch. This Engineer will need to have experience overseeing a manufacturing cell and will be required to validate all phases of the manufacturing process (vision systems, component qualification, cell automation and documentation). This will be a mostly high-volume manual production assembly process with 500k units produced per year. The engineer will support validation of suppliers, working cross functionally with the lifecycle team to drive line movement and oversee the ongoing project schedule. Prior experience within the medical device industry will be a plus to help adhere to GMP standards. Minimal local travel will be required and the on-site responsibilities will be 3 days a week in Blue Ash. Comfortable with some international travel, paced to increase in 2027. Both front end development and then back-end process after validation experience, so full Lifecyle.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