Job Search Results for medical device regulations

Insight Global is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards... More throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance.DUTIES AND RESPONSIBILITIES:? Lead the design assurance activities and support product development through design verification and validation.? Develop and execute risk management and design control documents, including DHF, DMR, and technical files.? Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.? Analyze testing data and prepare technical documentation for submissions to regulatory bodies.? Oversee design reviews and provide constructive feedback to team members.? Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.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

Summary: Under the supervision of onsite engineers, conduct investigations of suspected non-conforming devices and materials originating from patient and/or clinical reports of failure. Document... More investigation results within the complaint-handling tool, provide feedback on recurring issues, and escalate complaints when severity exceeds the expected level defined in the Risk Management file (RMM). Responsibilities also include general housekeeping, movement of devices back to the field via the inventory management system, and cleaning/disinfection of incoming suspected non-conforming material associated with complaints.Detailed Responsibilities:Support a dedicated departmental process with direct impact on med-tech products by collaborating with stakeholders to ensure smooth operations, demonstrating strong interpersonal and communication skills.Perform day-to-day operational tasks essential for technical complaint investigation support, exercising autonomy within established procedures.Participate in team meetings, contribute ideas, and capture accurate minutes reflecting discussions, decisions, and action items.Assist in preparing and presenting reports or findings for internal and external stakeholders, ensuring accuracy and clarity.Maintain up-to-date knowledge of industry trends, developments, and best practices while learning relevant technical skills and demonstrating a commercial and growth mindset.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 Project Manager to join their team. The Project Manager will be accountable to drive the Surgical Equipment Supply Chain deliverables required... More to progress critical R&D initiatives through our New Product Pipeline. Major Duties & ResponsibilitiesoLeadership through concept generation and execution for new product innovation projects.oCommunicates direction in ongoing strategic rationale for projects and for the planning, scheduling, monitoring, and reporting of projects.oAnalyzes, measures, and tracks project results, reports on progress, and optimizes program processes.oAccountable to follow processes and procedures to ensure the Supply Chain is informed, engaged and prepared to deliver the Value Stream strategies and/or Launch Management strategies. The role will need to drive cross-functional teams to alignment and delivery of project objectives. In addition, they will be ensuring their Value Stream Team and/or Launch Management team is informed and understands the health of the Supply Chain for the business segment(s). oEnsures governance compliance with all laws and regulations applicable to the department and its operations.oFacilitates risk assessments, drives informed decision-making, and ensures the resolution of critical issues.oManages aspects of team operations (e.g., workflow, performance, and compliance) and ensures achievement of team goals within established timelines and budgets.oThe Supply Chain Project Manager develops a strong understanding of the business segment including the Supply Chain as well as financial metrics/levers, marketing, insights, quality and business processes. oThey need to be able to demonstrate strong leadership, team skills, and communication skills and work within multiple levels of the Franchise. oThe accountabilities for the position include leading and facilitating interdisciplinary teams responsible for Supply Chain activities/projects necessary to enable the Launch Management projects to support the Portfolio.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 FPGA Engineer to join our client in Tucson, AZ. In this role you will?develop FPGA designs for all major vendors and device families including: Xilinx, Altera,?and... More Microsemi. Designs are implemented using VHDL for the following applications: gigabit serial interfaces, Radio Frequency (RF) and Electro-Optical (EO) DSP, controls, data links, embedded processing and processor interfaces. Designers work with circuit card designers and systems engineers to develop requirements, architect new parts, collaborative modeling of algorithms, partition and perform code development, simulation, and?place and route.?Designs are verified against requirements using both directed test and constrained random methodologies. Design support is expected from requirements definition through integration and test. Design documentation and configuration management are required. Responsibilities to Anticipate: ? Design and deliver production quality FPGA releases from initial proof of concept up to production ? Architect FPGA-based systems to determine parts, interfaces, and Concept of Operations (CONOPS) ? Translate system level requirements into FPGA requirements ? Design and code in VHDL for reliability and maintainability ? Verify designs utilizing self-checking techniques with directed and constrained random tests, while tracking functional and code coverage ? Help drive projects and execute to program schedules on time and budget ? Create complete documentation including requirements, verification plan, and user?s guides ? May support internal and external technical reviews ? May support customer interactions & relationsCompensation: $65/hr to $73/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages 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 lawWe 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 highly experienced and collaborative Senior Quality Engineer to join our client'sQuality team. This role will be instrumental in leading risk management activities, supporting new... More product introductions (NPIs), and sustaining engineering efforts for primarily Class I and II medical devices marketed in the US. The ideal candidate will bring experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a strong preference for experience in EU MDR technical documentation.Key Responsibilities? Own the creation, maintenance, and continuous improvement of Risk Management Files in accordance with ISO 14971.? Facilitate cross-functional risk assessments throughout the product lifecycle.? Partner with R&D to ensure quality is built into the design and development of new products.? Provide quality engineering support for design changes, product updates, supplier diversification, and post-market surveillance.? Provide process and test method validation expertise to suppliers and internal teams.? Ensure compliance with ISO 13485, FDA QSR, and internal quality system requirements.? Support internal and external audits.? Lead or support internal investigations, including CAPA and nonconformances.? Mentor and provide technical guidance across teams.? Foster a culture of quality, continuous improvement, and cross-functional collaboration.$85,000 to $100,000 - 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

? Perform SAP execution and transactional support, including master data maintenance and system updates.? Set up and maintain SAP master data objects, including: ? Material Master records? Planning... More and control parameters? Plant, network, and organizational structures? Monitor and analyze SAP data flows, identifying discrepancies, root causes, and downstream impacts across fields and modules.? Support data quality checks, audits, and remediation activities to ensure system accuracy and compliance with data standards.? Assist with new plant and network setups and ongoing system enhancements.? Execute system testing activities (unit, integration, UAT) and document results.? Support identification and documentation of user stories and functional requirements.Partner with cross-functional teams to resolve SAP issues and support continuous improvement initiatives.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 Senior EHS Specialist to support its Warsaw, IN manufacturing site, which produces advanced Cranial, Spinal, ENT, and Emerging Technology medical devices. This role is... More critical to driving a safe, compliant, and high-performing manufacturing environment in alignment with team's mission to alleviate pain, restore health, and extend life.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 Software Design Verification Engineer (Cybersecurity) leads software verification and validation (V&V) activities for medical device embedded software, with a strong focus on cybersecurity... More and regulatory compliance. This role is responsible for developing and maintaining software design verification processes, test strategies, project plans, and procedures; executing verification, regression, and cybersecurity testing throughout the development lifecycle; and designing automated test scripts and tools to support evolving embedded software releases. The engineer collaborates closely with engineering, quality, and project teams to coordinate test execution, participate in reviews and readiness activities, investigate issues, and deliver clear, compliant test documentation aligned with internal quality systems and regulatory requirements. In addition, this role contributes to continuous improvement through test automation and process optimization and supports team development by mentoring and training engineers and technicians on software design verification and cybersecurity testing practices.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 looking for a FPGA Engineer to join our client in Tucson, AZ. In this role you will?develop FPGA designs for all major vendors and device families including: Xilinx, Altera,?and... More Microsemi. Designs are implemented using VHDL for the following applications: gigabit serial interfaces, Radio Frequency (RF) and Electro-Optical (EO) DSP, controls, data links, embedded processing and processor interfaces. Designers work with circuit card designers and systems engineers to develop requirements, architect new parts, collaborative modeling of algorithms, partition and perform code development, simulation, and?place and route.?Designs are verified against requirements using both directed test and constrained random methodologies. Design support is expected from requirements definition through integration and test. Design documentation and configuration management are required. Responsibilities to Anticipate: ? Design and deliver production quality FPGA releases from initial proof of concept up to production ? Architect FPGA-based systems to determine parts, interfaces, and Concept of Operations (CONOPS) ? Translate system level requirements into FPGA requirements ? Design and code in VHDL for reliability and maintainability ? Verify designs utilizing self-checking techniques with directed and constrained random tests, while tracking functional and code coverage ? Help drive projects and execute to program schedules on time and budget ? Create complete documentation including requirements, verification plan, and user?s guides ? May support internal and external technical reviews ? May support customer interactions & relations Benefit packages 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

Insight Global is looking for a FPGA Engineer to join our client in Tucson, AZ. In this role you will?develop FPGA designs for all major vendors and device families including: Xilinx, Altera,?and... More Microsemi. Designs are implemented using VHDL for the following applications: gigabit serial interfaces, Radio Frequency (RF) and Electro-Optical (EO) DSP, controls, data links, embedded processing and processor interfaces. Designers work with circuit card designers and systems engineers to develop requirements, architect new parts, collaborative modeling of algorithms, partition and perform code development, simulation, and?place and route.?Designs are verified against requirements using both directed test and constrained random methodologies. Design support is expected from requirements definition through integration and test. Design documentation and configuration management are required. Responsibilities to Anticipate: ? Design and deliver production quality FPGA releases from initial proof of concept up to production ? Architect FPGA-based systems to determine parts, interfaces, and Concept of Operations (CONOPS) ? Translate system level requirements into FPGA requirements ? Design and code in VHDL for reliability and maintainability ? Verify designs utilizing self-checking techniques with directed and constrained random tests, while tracking functional and code coverage ? Help drive projects and execute to program schedules on time and budget ? Create complete documentation including requirements, verification plan, and user?s guides ? May support internal and external technical reviews ? May support customer interactions & relationsCompensation: $73/hr to $96/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages 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 lawWe 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