Medline

Job Summary Job Description JOB SUMMARY Deliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner. MAJOR RESPONSIBILITIES Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations. Ensure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements. Coordinate, Execute, and Report on validation plans for custom and off-the shelf software. Manage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer informed and satisfied. Document validation protocols and reports with professional and technical written communication skills. Know, support, and conform to Medline policies and relevant governing procedures. Maintain awareness to industry and regulatory environment, including FDA, GAMP, ISO. Maintain organizational excellence, including document control, quality records, detail, and thoroughness. Evaluate ways to streamline and improve efficiencies in software validation and associated processes. Provide team support in all validation initiatives as requested. Support development and upkeep of Divisional SOPs as related to software use. Provide system design feedback to ensure compliance with regulatory and Medline standards throughout the software development life cycle. MINIMUM JOB REQUIREMENTS Education: Bachelor's degree in Engineering, Quality, Business, or Computer Science. Work Experience: 5+ years of experience in Manufacturing, Quality or Engineering. 3+ years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating. Direct experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures. Additional Experience applying knowledge of standard concepts, practices, and procedures within software engineering. Experience and skills in influencing, leading and directing individuals in multiple functional areas. Experience with project management (for example: planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives). PREFERRED JOB REQUIREMENTS Work Experience: Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.). Experience with the following: - QMS - ISO13485:2016 - 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling - GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5) - ISO / Customer / Regulator Audits - FDA Product and Establishment Registration - GS1 / GUDID Management - Quality Management System / Medical device environment experience. Proficient in MS Word, Project, Excel. Experience in people and process management. Continuous improvement and Kanban related project experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $101,000.00 - $152,000.00 Annual The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Job Description JOB SUMMARY The Business Systems Analyst Lead role will support discovery workshops with our business stakeholders and document technical specifications and designs in an agile Environment. This role will also be responsible for requirements gathering, discovery, performing gap and data analysis and functioning as a key point of contact for our business stakeholders. The role will also be expected to handle complex issues across divisions. MAJOR RESPONSIBILITIES Business System Analysis and Administration: Conduct requirements gathering and discovery workshops with business stakeholders. Serve as technical lead for Ironclad CLM projects providing oversight and collaborating on architectural design, reviews and optimization. Work with business partners and product owners assisting with the creation of system requirements for the product backlog. Perform gap and data analysis in support of identifying improvement opportunities. Support technical team members by providing functional clarification and setting expectations with team and clients. Document requirements, create specifications and/or wireframes, change requests, test cases, user guides, and strategy roadmaps. Execute test cases and ensure overall quality of solution is a plus. Assist the business partners with UAT testing. Facilitate system requirements meetings with the product teams. Able to perform proxy product owner duties. Conduct peer reviews and provide guidance to other team members as needed. Observe the team's delivery workflow and suggest changes in process/tooling to gain efficiency. Focus on building partnerships with cross division teams to promote collaboration and build effective solutions that span across multiple business units. Ensure movement / success of all tasks owned by the team. Able to lead team of business analysts. Monitoring and Support: Collaborate with infrastructure and application development teams to design an effective system monitoring & alerting plan. Respond to any system anomalies like performance or vulnerability alerts and partner with respective teams to remediate them. Respond to inquiries from business partners, requests from users, support calls/tickets escalated by help desk. Author and maintain knowledgebase for the effective resolution of repetitive requests, inquiries, and requests. Conduct root-cause analysis for system related incidents. Facilitate root-cause analysis for incidents related to infrastructure or other externally managed dependencies. People Management: While not having direct reports, this position will partner with the team manager on matters like capacity management, maximizing the throughput of the available staff, employee feedback, retention, etc. This role will be seen as a mentor by other team members. Conduct peer reviews, provide guidance on specific matters and coach the team to elevate their performance and develop their skills. MAJOR RESPONSIBILITIES Release Management: Understand and adhere to IS change management policies. Identify and execute best practices to ensure a streamlined, reliable deployment and a streamlined, reliable roll-back process. Demonstrate good judgement on risk and impact for various types of changes done by the team. Ability to grade appropriately critical/highly visible changes vs routine/low risk changes. MINIMUM JOB REQUIREMENTS Education A bachelor's degree in computer science or related field. Or equivalent work experience with desired systems and technologies. Work Experience 7+ years of experience in business analysis and configuration on relevant platforms. 5+ years of experience implementing and leading CLM applications, with a strong emphasis on Ironclad (Must be an Ironclad Subject Matter Expert). Preference given to candidates who are Ironclad Bootcamp Certified Hands-on expertise with Ironclad's configuration, workflow automation, Smart Import, Smart Contract capabilities, and API-based integrations Deep background in business rules, custom calculations and data integration utilizing various CLM tools 3+ year in an operations role providing production support for large enterprise grade applications. Knowledge / Skills / Abilities Strong analytical skills to understand business goals and design appropriate solutions. Ability to independently design, build and troubleshoot highly complex features. Understanding of software development lifecycle, as well as agile software development methodologies. General awareness of web and cloud technologies, differences between SaaS, PaaS and on-premises hosted system deployments. Excellent verbal and written communication. Strong interpersonal and relationship management skills. Ability to work independently as a self-starter, and within a team environment. Click here to learn more about a career in IT at Medline! Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary The Senior Design Engineer researches, designs, develops, and supports complex medical devices with a focus on electrical and system design. This role provides technical leadership and subject matter expertise across the full product lifecycle, from concept through commercialization; leads electrical and system level design efforts; translates user needs into compliant design specifications; mentors junior engineers; collaborates cross functionally; and drives design excellence to support successful product launches and continuous improvement. Job Description Responsibilities: Lead the electrical and system level design of medical devices, including architecture definition, requirements decomposition, and interface control across hardware, firmware, and software domains. Design and develop electrical schematics, PCB layouts, and supporting documentation using ECAD tools. Contribute to and review software and firmware architectures, ensuring robust integration with electrical hardware and system requirements. Drive design transfer activities, ensuring smooth transition from R&D to manufacturing through validation builds, process development, and troubleshooting. Support intellectual property strategy by identifying novel design concepts and partnering with legal to secure patents. Define and manage system requirements, perform feasibility studies, and ensure traceability through design inputs, outputs, verification, and validation activities. Integrate human factors and user centered design philosophies into product development to enhance safety, effectiveness, and user satisfaction. Lead multi-disciplinary product development teams to research, design, and develop better products and technologies. Ensure product designs meet all design specifications. Manage multiple projects by coordinating resources, and priorities to meet development milestones and business objectives. Evaluate and improve existing products through root cause analysis, risk assessments, and feedback from users, manufacturers, and post-market surveillance. Contribute to innovation pipelines by collaborating with product divisions to identify new product opportunities, and align product design efforts with long-term strategic goals. Qualifications: Education Bachelor's degree in Electrical Engineering, Electrical & Computer Engineering, Software Engineering, Biomedical Engineering, or a related engineering discipline Work Experience 4+ years of experience in electrical and/or system level product design, preferably within a regulated industry. Hands on experience with schematic capture, PCB design, and prototype bring up. Advanced proficiency in Altium Design or equivalent E-CAD software. Experience with prototype development, PCB manufacturing, design documentation, and design for manufacturability. Experience working with embedded systems, including hardware software integration and system debugging. Demonstrated experience working within a structured product development process, including exposure to design controls, risk management, and cross-functional collaboration. Preferred Qualifications: Experience in product design within the medical device industry, including development and launch of Class II devices. Strong understanding of design controls, risk management (e.g., FMEA), and regulatory documentation (e.g., DHF, DMR, traceability matrices). Familiarity with medical electrical safety, EMC, and compliance testing (IEC 60601, IEC 62304, ISO 14971). Experience with embedded firmware/software development or architecture, including requirements definition and verification. Experience leading or significantly contributing to cross disciplinary system architectures. Experience supporting products through manufacturing scale up and sustaining engineering. Strong technical documentation, communication, and project coordination skills. Knowledge / Skills / Abilities Position requires travel up to 10% of the time for business purposes (domestic and international). Strong understanding of electrical systems, embedded software interactions, and system engineering principles. Ability to troubleshoot complex hardware software system issues. Effective collaboration in multi disciplinary development teams. Ability to manage technical risk and make sound engineering decisions in a regulated environment. Familiarity with regulatory standards including IEC 60601 Series, FDA 21 CFR Part 820, ISO 13485, and ISO 14971. Effective communication and collaboration skills, with experience working in cross-functional teams. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $101,000.00 - $152,000.00 Annual The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Job Description Medline Industries, LP is seeking Architects IT to join our team in Northbrook, IL. Job Description: Lead evaluation, design, and analysis for implementing solutions architecture, and collaborates with management, business leaders, and stakeholders. Identify organizational and financial impacts of the solution's architecture. Translate business and technical requirements into an architectural blueprint, and document all design and analysis work. Work closely with Product Owners to support future business requirements. Develop end-to-end project solutions, designs, and execution approaches. Define project risks and gaps and leads efforts to resolve them. Collaborate with external partners for solutioning, implementation, and execution. Influences and guides stakeholders and peers with decision making. Work effectively in a team environment and leads cross-functional teams. Design and oversee scalable, secure eCommerce solution architectures using Azure cloud technologies, including integrations between customized eCommerce platforms and internal and external systems. Design security architectures using encryption, multi-factor authentication, OAuth2, and API management to protect customer data and ensure compliance with internal security standards. Telecommuting is permitted, but applicant must work from the worksite location at least 3 days per week. No additional national or international travel is anticipated. Job Requirements: PRIMARY REQUIREMENTS: Bachelor's degree in Computer Science, Information Technology, Systems Engineering, Engineering, Chemical Engineering or related field, or its foreign equivalent, and 5 years of relevant work experience. In addition, experience with the following skills is required: (1) Experience in architecting secure applications for Healthcare with knowledge of PHI, PII, and HIPAA compliance; (2) Experience in designing cloud-native applications (Azure) and knowledge of Azure native services; (3) Experience in data governance, technology standards management, business application rationalization, and application portfolio management; (4) Experience understanding reference architecture patterns and well- architected frameworks, understanding of high availability, application recovery, and cloud infrastructure resiliency; (5) Experience with various database technologies including MSSQL, MongoDB, Oracle, and HANA; (6) Experience understanding product management, agile principles, development methodologies, and the capability of supporting agile teams; and (7) Experience with enterprise technology architecture aspects including business, information, data, network, and security. JOB SITE: 2375 Waterview Drive, Northbrook, IL 60062 WORK HOURS: Full Time (8am to 5pm, Monday to Friday) PAY RANGE: $134,000.00 to $201,000.00per year Click here to learn more about a career in IT at Medline! Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.