Job Search Results for medical device regulations

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

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

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

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

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

This role will support a global, mission-driven medical technology company developing cloud-connected, software-driven products that integrate with mobile applications and data platforms in a highly... More regulated environment. The Senior Systems Test Engineer will lead the definition, analysis, and management of software and system requirements for cloud-integrated solutions, partnering closely with product, software engineering, quality, and regulatory teams. This individual will translate user needs and product requirements into clear, testable software and system requirements, maintain end-to-end traceability, and ensure design outputs meet regulatory and quality standards. The role is hands-off from a coding perspective and instead focuses on requirements development, technical reviews, risk management, and alignment across cross-functional stakeholders to support compliant, scalable cloud-enabled products.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

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