Job Search Results for medical device

A large medical device company is looking for a Technical Project Manager to support growing Unique Device Identification (UDI) initiatives driven by increasing global regulatory requirements. This... More role blends technical data expertise with project management leadership, supporting multiple UDI and digital product information projects critical to regulatory compliance and health authority submissions worldwide.The ideal candidate brings a strong understanding of large-scale data management, data validation and reconciliation, and project execution, with the ability to navigate complex regulatory timelines while collaborating across cross-functional 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

Job Description SummaryQA Acceptance Inspector 30: Carries out independent activities that support the execution of regulatory and quality management system requirements related to incoming... More inspection and/or sorting of suspect materials for medical devices, consumer goods, or other products within warehouse and/or factory facilities.Job Description?Perform incoming inspection and/or sorting of suspect materials for medical devices.?Create timely nonconforming records for failed inspections and/or sorting of suspect nonconforming medical device components.?Responsible for meeting departmental metrics.?May assist with daily management board activities, including data input.?Support lean initiatives and contribute to continuous improvement efforts.?Escalate issues to direct manager as needed.?Complete work with some supervision.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

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

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

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'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

Insight Global is seeking a Community Engagement Marketing Associate for one of our medical device clients. This role will support field-facing marketing initiatives that focus on community... More education, event logistics, and coordination with sales teams. The ideal candidate is highly organized, responsive, and comfortable working in a fast-paced environment that requires strong follow-through and attention to detail. This position plays a critical role in supporting Community Health Talks (CHTs) and related field marketing programs. Rather than campaign strategy or marketing automation, this role is focused on execution, coordination, and tracking to ensure events are launched smoothly and delivered on time.Key Responsibilities- Serve as the primary marketing support contact for Community Health Talks, from initial request through event completion- Partner closely with territory managers and field sales teams to coordinate event logistics and timelines- Manage all required event components, including: Physician agreements, Approved presentation decks and best-practice materials, Promotional assets and event setup- Coordinate with external agencies to support: Event logistics, Media placement, Virtual or in-person setup as needed- Track event activity, attendance, and follow-up outcomes using Excel-based tracking tools- Maintain light activity updates and records within Microsoft Dynamics (no advanced configuration or automation)- Support internal reporting by documenting: Number of events completed, Attendee metrics, Follow-up requirements- Assist marketing leadership by taking on tactical execution work that supports broader field marketing initiativesWe 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/.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

?Tag medical equipment with RTLS (Real-Time Location Services) stickers?Match RTLS tags to device IDs within the client?s mobile application?Ensure accuracy and attention to detail during tagging and... More data entry?Identify which medical devices are in scope for tagging?Communicate process improvements and flag risks to the project leadWe 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 looking for a Senior Quality Engineer to support a new product development project. This role is responsible for managing risk management documentation across the product... More lifecycle, including maintaining risk files for marketed products, supporting the development of new product risk documentation, and improving overall risk management systems. The position ensures compliance with ISO 14971 and regulatory requirements by reviewing submissions, responding to regulatory inquiries, and staying current on evolving standards. It also supports audits, monitors risk metrics, and escalates changes in product risk profiles as needed. The role partners cross-functionally with teams such as Medical Safety, Manufacturing, and Post-Market Surveillance to ensure alignment, while providing regular reporting, facilitating meetings, and driving continuous process improvements.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