Job Search Results for medical device

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

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

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

We are looking for a skilled Principal Engineer to join our team! As a Sr. Software Engineer, Platform Data, you will be a key technical contributor responsible for designing, developing, and... More integrating data management solutions for System Integration digital platforms in medical device domains. We are seeking an experienced engineer with deep expertise in clinical data ecosystems, specifically utilizing HL7 v2 and DICOM standards. The ideal candidate will have hands-on experience across multiple technology stacks?with strong proficiency in C#, Azure Cloud Services, database architecture, and DevOps practices. In this role, you will be expected to operate as a highly capable individual contributor who can immediately drive project deliverables, solve complex technical challenges, and ensure we meet our strategic goals and schedulesCompensation:$8/hr Exact compensation may vary based on several factors, including 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 Clinical Study Enablement Business Analyst?to support a leading medical device client?s Global Clinical Operations Technology & Enablement / Global Clinical IT?team. In... More this role, you will play a key part in enabling clinical study execution by supporting study setup, data validation, and system testing within regulated clinical environments. This position focuses heavily on Electronic Data Capture (EDC) platforms?and downstream data and reporting solutions. You will partner closely with clinical and technology stakeholders to translate business needs into clear, actionable requirements, validate clinical data, and ensure systems and studies are fully prepared for go-live. This is a hands-on, delivery-focused contract role?well suited for an experienced, self-directed analyst who is comfortable working independently and navigating the complexities of clinical systems and regulatory standards. This is a hybrid role working onsite at one of the company locations in India 3x a week.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 Validation Engineer for a long-term opportunity. This Validation 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 equipment development engineer will be validating equipment while 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

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

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

One of our large Medical Device companies is seeking a Quality Validation Engineer for a large project. The Quality Validation Engineer will lead and support validation and qualification activities... More for heat-seal processes and related raw materials, ensuring compliant execution of IQ/OQ/PQ documentation, robust change control, and alignment with the Quality Management System (QMS).?Author, review, and execute qualification documentation (IQ/OQ/PQ protocols and reports) for material processes, ensuring traceability to requirements and acceptance criteria.?Lead and support implementation, qualification, and validation of new raw materials and process changes for production lines ?Support process characterization activities by preparing test strategies, data collection tools, and executed test records; compile, analyze, and summarize results to support qualification conclusions.?Manage and support change control activities (change requests/records), including impact assessment, risk assessment (e.g., FMEA), implementation actions, and required documentation updates.?Review, maintain, and improve controlled documents (quality procedures, test methods, and specifications) in support of process and product validation.?Ensure qualification/validation packages are complete and compliant, including executed protocols, deviation documentation, investigations, final reports, and approvals per the QMS.?Provide technical input to investigations, deviations, nonconformances, and CAPAs, including containment/bounding, root cause analysis, action effectiveness, and timely closure.?Ensure day-to-day activities align with applicable requirements (FDA 21 CFR 820, ISO 13485, GxP) and support internal/external audits through documentation readiness and response support.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