Job Search Results for medical device regulations

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

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

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

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. 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

Our client is seeking a reliable and hardworking Warehouse Associate to join their growing team at their Milwaukee facility. This role is primarily focused on device receiving and inventory... More management during the first 2?3 hours of each shift, after which the associate will transition to support the White Glove onboarding team for the remainder of the day. The ideal candidate is an early riser who is comfortable with physical labor, works well in a team environment, and is eager to learn new systems and processes.Responsibilities?Receive and process incoming device shipments as they arrive at the Milwaukee office?Track and manage device inventory accurately?Lift, move, and organize heavy boxes and equipment throughout the warehouse?Wrap pallets and maintain an organized warehouse environment to support the White Glove onboarding team?Transition to support the White Glove team after completing morning receiving duties to assist with device onboarding?Log and document device activity using ticketing systems (Autotask)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

Insight Global is looking for a Senior C# Engineer to join one of our global manufacturing and supplier clients. This person will a specialized R&D team that is pioneering high-accuracy... More micro-location technologies that rely on advanced algorithms to achieve centimeter-level precision. By blending sensor data, RF signals, and cutting-edge signal processing, they are transforming how people and machines navigate their environments. This person will join a team to tackle complex real-world problems with creativity, collaboration, and a spirit of continuous innovation. Responsbilites include:?Design and develop high performance backend services using C# and .NET running in Linux server environments.?Architect and implement scalable service oriented systems that support high throughput messaging, device communication, and distributed workloads.?Design and build network based services.?Develop and maintain systems that leverage distributed messaging technologies such as Kafka, MQTT, RabbitMQ, or similar platforms.?Implement secure service architectures, including authentication, authorization, encryption, and secure communication patterns.?Design backend infrastructure with high availability, scalability, observability, and fault tolerance as core principles.?Optimize service performance through asynchronous programming, concurrency models, and efficient resource management.?Develop and maintain APIs and service interfaces used by internal systems, connected devices, and cloud platforms.?Collaborate with DevOps and infrastructure teams to support deployment pipelines and operational tooling across cloud environments such as AWS, Azure, or GCP.?Troubleshoot and resolve complex issues involving network communication, distributed systems behavior, and production service performance.$50/hr to $70/hr : Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages while on contract for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.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

Our client is seeking a reliable and hardworking Warehouse Associate to join their growing team at their Milwaukee facility. This role is primarily focused on device receiving and inventory... More management during the first 2?3 hours of each shift, after which the associate will transition to support the White Glove onboarding team for the remainder of the day. The ideal candidate is an early riser who is comfortable with physical labor, works well in a team environment, and is eager to learn new systems and processes.Responsibilities?Receive and process incoming device shipments as they arrive at the Milwaukee office?Track and manage device inventory accurately?Lift, move, and organize heavy boxes and equipment throughout the warehouse?Wrap pallets and maintain an organized warehouse environment to support the White Glove onboarding team?Transition to support the White Glove team after completing morning receiving duties to assist with device onboarding?Log and document device activity using ticketing systems (Autotask)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