Job Search Results for medical device regulations

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

A Fortune 500 company is seeking a candidate to join a growing quality engineering team supporting the development of a cutting-edge medical device. This individual will work closely within agile... More scrum teams to plan and execute both manual and automated testing across new and existing software features. They will review product requirements to ensure testability, build and maintain automated test scripts, and perform functional, performance, load, and reliability testing to ensure product quality. The role also involves validating design changes, maintaining detailed test documentation, and ensuring compliance with regulated medical device standards. In addition, this individual will support AI-enabled functionality by preparing validation datasets, analyzing model metrics, and identifying test scenarios that have the greatest impact on end users and customers. This role is hybrid, 3 days onsite, Wednesday required.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

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

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

These people will add technical efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on analyzing product performance data across Interventional Cardiology and Vascular... More Therapies (ICVT) devices. These members evaluate post-market surveillance data, including complaints and adverse events, to identify, investigate, and resolve safety or quality issues in compliance with regulatory and internal requirements. They will support product signal escalations by performing root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement. The roles implement compliant process improvements, communicate product performance insights to leadership and design teams, and support performance reporting and customer inquiries. These people maintain a strong commitment to patient safety, product quality, and adherence to the Quality Policy and 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

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

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

R&D Manager ? Product Engineering (Capital Sustaining)Location: Marlborough / Greater Boston AreaWork Model: Onsite ? 5 days per week (flexibility expected over time, but the role should be... More positioned as onsite)Division: Research & DevelopmentTeam Size: 3 engineers currently (including 2 Lead Engineers, with planned growth)About the RoleA leading medical device organization is seeking an R&D Manager ? Product Engineering to support the sustaining and evolution of a complex capital equipment portfolio. This role is accountable for ensuring product reliability, regulatory compliance, and long-term lifecycle viability across Class II medical devices.This is a highly hands-on, onsite leadership position that requires close, day-to-day collaboration with Manufacturing, Design Assurance, Quality, Lifecycle Management, and Post-Market teams. The ideal candidate is comfortable operating in ambiguity, can effectively triage competing priorities, and is willing to step in where needed to keep critical workstreams moving forward.A significant focus of this role will be on legacy portfolio visibility, remediation efforts, and lifecycle decision-making. The manager will play a key role in strengthening overall quality, compliance, and sustaining engineering practices across the broader organization.Key ResponsibilitiesProduct Sustaining & Lifecycle Management? Lead sustaining engineering activities for a portfolio of capital medical devices, balancing technical, regulatory, and business priorities.? Own and guide end-of-life (EOL) strategies, including component obsolescence, product replacement planning, re-testing, rationalization, and next-generation replacement efforts.? Drive decision-making around when to remediate, redesign, replace, or retire products, ensuring patient safety, compliance, and continuity.? Act as a ?player-coach?, stepping in as needed to fill technical or execution gaps and keep initiatives moving forward.Remediation, Quality & Compliance? Partner closely with Quality and Design Assurance to lead and execute remediation programs across legacy products and multiple business units.? Improve the overall approach to quality and compliance, driving visibility, structure, and accountability across the legacy portfolio.? Ensure products and engineering activities remain aligned with internal QMS, FDA Design Controls, Risk Management requirements, and ISO 13485 standards.? Support and lead CAPA-driven remediation efforts, working hands-on with quality partners to define and execute corrective actions.? Provide a strong engineering perspective when working with quality teams?constructively pushing back where needed to ensure remediation plans are technically sound, risk-based, and pragmatic.? Maintain awareness of compliance considerations such as EMI/EMC and applicable regulatory testing requirements.Cross-Functional & Manufacturing Collaboration? Work closely and daily with Manufacturing teams, lifecycle management partners, and post-market colleagues to resolve field issues, manufacturing challenges, and customer-reported defects.? Triage incoming demands from multiple stakeholders, helping prioritize work that delivers the greatest impact and makes the most technical and business sense.? Serve as a primary interface between Engineering, Manufacturing, Quality, Design Assurance, and Post-Market teams, clearly communicating tradeoffs and priorities.Team Leadership & Vision? Lead and develop a small but critical team of engineers, currently consisting of 2 Lead Engineers, with plans to grow.? Establish a clear vision for a new and evolving team, including how the group should scale, where capabilities need to expand, and what success looks like.? Balance people development and technical credibility?this role values both strong leadership acumen and deep engineering experience.? Manage performance, provide coaching and feedback, and support professional growth.? Bring prior people management experience, while remaining comfortable working within a lean team environment.Program & Execution Management? Apply strong program management discipline to manage multiple parallel initiatives across remediation, sustaining engineering, and lifecycle updates.? Allocate resources effectively across Lifecycle Management, Quality, and Compliance initiatives.? Communicate clearly and effectively with both technical and non-technical stakeholders through documentation, presentations, and regular updates.? Advocate for and manage the team?s budget and resourcing needs.Compensation: $122,000 to $190,000. 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 experienced Laboratory Solution Account Manager to join our client in the healthcare technology space on a full-time basis. The Laboratory Solution Account Manager will... More be based in Ontario, supporting the assigned territory (SW). The successful candidate will be working with the Market Development Manager within the region as the account owner to develop and promote core and specialty product solutions within the hospital, hospital laboratory, private laboratory, and other healthcare institutions. In this role, you will be interacting and selling to all levels of customers in the specified target account (CEO?s, Purchasing, Laboratory Management, Biochemists, Laboratory Technologists, Medical Directors, etc.), preparing complex financial product acquisition proposals, tender responses including RFP response preparation., as well as identifying and developing business opportunities for healthcare solutions as part of a cross functional team. This is a role well-suited to an ambitious sales professional from the medical technology sector looking for the next step in their career. This opportunity includes a PTO package, base salary + commission, health/dental benefits, as well as travel comp.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