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

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

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

A Technical Project Manager will join a fast-paced medical device environment to lead and coordinate cross-functional initiatives spanning AI-enabled solutions, cybersecurity programs, and corporate... More IT projects. This individual will serve as the bridge between engineering, security, IT, quality, and business stakeholders, owning project planning, execution, and delivery while ensuring alignment with regulatory, data privacy, and patient safety requirements. The role requires translating complex technical concepts into clear project plans, managing timelines, risks, dependencies, and budgets, and driving accountability across internal teams and external partners. The Technical Project Manager will support initiatives across the full project lifecycle?from discovery and requirements definition through implementation, validation, and post-deployment support?while ensuring adherence to relevant medical device standards, internal governance, and security best practices. This position is ideal for someone who is comfortable operating in highly regulated environments, managing multiple technical workstreams, and enabling teams to deliver impactful, compliant, and scalable technology solutions.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 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

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

Insight Global is seeking a Transformational Project Manager to support a high-visibility Biosurgery Portfolio Transformation initiative for a leading Medical Device client. This is a hybrid contract... More role (3x/week onsite) based in Raritan, NJ or Cincinnati, OH, through the end of the year.This individual will sit within US Marketing and serve as a centralized portfolio enablement and execution oversight lead across five pilot workstreams tied to a broader biosurgery transformation strategy. These pilots focus on commercial adoption, portfolio lifecycle management, and behavioral change across surgeons and customers. The goal of this role is to bring structure, visibility, and actionable insights across these pilots to inform near-term execution and shape the 2027 biosurgery portfolio strategy.This is not a traditional PMO role?it requires a strong commercial lens, cross-functional influence, and the ability to translate insights into business recommendations, rather than purely managing timelines or technical deliverables.Pilot Oversight & Portfolio Visibility?Provide centralized oversight across 5 biosurgery pilot workstreams, ensuring alignment on objectives, milestones, and outcomes?Establish governance structures, reporting cadence, and visibility across all pilots?Own portfolio-level reporting, with selective ownership of execution for specific pilotsInsights, Reporting & Business Recommendations?Synthesize pilot data (provided by analytics teams) into clear, actionable insights and recommendations?Identify key performance drivers and barriers, including: Pricing challenges, Training/education gaps, and Adoption behaviors across surgeons/customers?Translate insights into commercial strategies and messaging to influence behavior and drive adoption?Develop executive-ready dashboards, summaries, and storytelling materialsCross-Functional Collaboration?Partner closely with: US Marketing, Global Strategic Marketing (GSM), Supply Chain, Analytics/Data teams and External strategic partners?Drive alignment across a highly matrixed organization, influencing stakeholders without direct authority?Facilitate discussions, manage risks/issues, and ensure follow-through on key decisionsExecution Enablement ?Support execution by: oEstablishing workback plans and timelinesoTracking risks, dependencies, and blockersoEscalating issues and driving resolution?Act as a strategic lens and connector, rather than fully owning end-to-end execution of every pilotWe 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

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

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