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

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

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 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

The Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S.... More regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This role is critical to the company?s next phase of growth and will lead a significant overhaul of regulatory processes, ensuring the organization is prepared for increased regulatory scrutiny, expanded product claims, and future global market access.This individual will operate in a lean, evolving environment, where ambiguity is common and ethical decision-making is paramount. The successful candidate will be hands-on, pragmatic, and capable of building structure where little currently exists, while serving as a strategic regulatory partner to senior leadership.This role is an individual contributor with the opportunity to grow into people leadership. Top Priorities ?Regulatory remediation and reclassification efforts across a large portfolio (~2,000 products), supporting the transition from Class I to Class II?End-to-end regulatory impact assessments, including labeling, claims, and submission strategy?Health hazard evaluations ?Risk analysis ?MDR (medical device reporting)?Establishing foundational regulatory processes to support scale, audits, and future submissions$140,000 to $150,000. - 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 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

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

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

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