Job Band: Job Band 13 (JB13) Hiring Manager: Akhil Kodiyamtharappel Sadasivan Lead Recruiter: Tino Manimuthu Country: India Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential. JOB SUMMARY: - Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines. REPORTING: - Reports to Deputy Manager QC ESSENTIAL DUTIES: - Administration/Internal Communications: Responsible for completing testing as part of Chemical, Functional and incoming inspection. Responsible for Document Review and Approval Responsible for providing support to Global Quality projects. Responsible for providing support to complete gap assessments. Other duties and responsibilities Responsible for Analysis and inspection of raw materials, accessory items and finished product. Responsible for Document and Test Report Reviews and Approval Responsible for In-process Testing and water testing. Responsible for making sure that data is accurately recorded in accordance with guidelines. Responsible for reporting, trending, and presenting results. Responsible for Calibration of Glassware and Instruments. Responsible for ensuring products are complying to the established regulatory guidelines with respect to product compliance. Responsible for ensuring GLP and cGDP requirements are in place. Responsible for supporting WCM, Lean, Six Sigma projects, root cause analysis, Productivity projects. Responsible for empowering people by giving required training Responsible for qualification of analytical instruments and QC equipement Responsible for New product evaluation and stability studies. Responsible for Monthly trending of test results. Responsible for subcontractor training and audits. MINIMUM QUALIFICATION REQUIREMENTS: - Education: Master s degree in chemistry or Bachelors Degree in Pharmacy or Master s Degree in Pharmacy (Pharmaceutical Analysis / Pharmaceutics / Pharmaceutical Chemistry) Experience: 7 to 10 years of experience in Testing laboratory of pharmaceutical industry. Technical Experience/knowledge and Skills required in below. Knowledge on instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/ etc) Knowledge on performing test as per Pharmacopoeial requirements (USP/IP/EP) Data Integrity Knowledge on different type of chemical analysis Able to understand and identify key objectives across the business. Able to deal with multiple issues, tasks and priorities concurrently. Knowledge about Analytical/Microbiological test and Equipment Qualification Preferable to have Knowledge about USFDA/EuGMP requirements. Need to work in all 3 shifts including night shift on requirement. Additional Requirements Capable to work in all shifts including All three shifts (Night Shift on requirement). Have strong communication skills complimented with right technical skills to drive meaningful discussions.

Software Systems Engineer JOB SUMMARY This role is responsible for the following as they relate to complex medical devices and their associated software applications: Develop clear, concise software requirements, behavior, and feature definition Participate in software planning and estimation Requirements allocation and traceability Software integration strategy and planning ESSENTIAL DUTIES Project: Lead simple programs or support more senior associates on large programs consisting of several software development teams including global partner teams with limited oversight. Define software behavior (requirements, environment, performance, etc.) for complex medical devices using a hybrid Waterfall-Scrum software development methodology, balancing structured planning with iterative development to meet project timelines while ensuring adherence to quality standards and customer requirements. Gather and prioritize scope inputs, with support from more senior associates, from diverse stakeholders including Business Area Leaders, Platform Tech Leads, Systems Engineering, Innovation, Software Development, Marketing, and Cybersecurity Teams. Define system behavior, use environment, requirements, feature definition, use case scenarios, full error paths, corner cases, and design constraints to ensure comprehensive project scope and functionality that meets customer needs. Collaborate effectively with multidisciplinary teams (systems engineering, software engineering, marketing, commercialization, regulatory affairs, quality assurance) to achieve customer requirements, design control objectives, and regulatory standards. Obtain formal cross-functional agreement of scope and priority of each project scope subset prior to starting software design and development with support from more senior associates. Manage scope changes throughout the project lifecycle with support from more senior associates. Collaborate with UI/UX designers, customer-facing associates, and human factors to create and optimize user interface design. May visit customer sites to gain firsthand knowledge of how users interact with the system in their environment and to determine customer needs. Work with software architects to define system behavior, allocate requirements, and review architectural design documentation with support from more senior associates. Collaborate with software architects to ensure functional and non-functional requirements are allocated to design elements and architecture with support from more senior associates. Own the interface control document which includes all software interfaces with support from more senior associates. Develop the integration test strategy and planning for a project with support from more senior associates. Ensure that integration points are satisfied before moving forward. Enforce project stage gates to ensure design controls adherence and best software lifecycle practices with support from more senior associates. Process: Contribute to meaningful, efficient, and consistent processes. Assist in identification of potential improvements. Behaviors: Ability to identify, communicate, and propose mitigations to project risks that may impact delivery timelines. Consistently deliver high-quality results and meet deadlines. Deep end-to-end, hands-on knowledge of complex systems and their field applications including all system domains, i.e. hardware, software, disposables, labeling, embedded software, and interfacing software applications. Become a go-to person and system subject matter expert. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor of Science degree in Computer science or Engineering or other science (e.g. chemistry, physics, biology). Experience Minimum 2-5 years of experience in developing medical device software compliant with IEC 62304:2006 / AMD 1:2015 Software life cycle processes for medical devices standard . Development of software to a similar standard or level of rigor also acceptable (e.g. aerospace). Knowledge of risk management processes, including FMEA (Failure Mode and Effects Analysis). Expertise in utilizing FMEA to analyze potential failure modes, prioritize risks, and develop robust mitigation strategies. Functional knowledge of ISO 14971:2019 Application of risk management to medical devices standard . Experience in defining and documenting system and subsystem requirements for systems and software solutions. Proficient in adhering to ISO/IEC/IEEE 29148:2018 Systems and software engineering standard to ensure comprehensive and structured requirements engineering. Familiar with requirements traceability management tools to manage requirements and traceability between requirements, design elements, software test artifacts, interface controls, risk control measures, and outputs. Skills Attention to Detail: Meticulous attention to detail in all tasks and projects. Behavioral Modeling: Consistently model exceptional behaviors, contributing to a positive and productive work environment. Collaboration and Team Contribution: Skilled in fostering open communication and collaboration. Communication and Presentation: Clear communication and effective presentation skills. Communication Skills: Superior written and verbal communication abilities. Critical Thinking: Apply critical thinking skills to analyze problems. Decision-making and Problem Solving: Proficient in identifying and resolving issues promptly. Effective Communication: Proven ability to communicate effectively both verbally and in writing. Lab environment: Should not be sensitive to the sight or discussion of blood or needles. Both human and bovine blood is used where necessary, in addition to visiting customer sites where our equipment is used in a clinical or donor environment. Listening and Observational Skills: Strong listening and observational skills. Organizational and Time Management: Excellent time management skills. Ownership and Follow-through: Proactively pinpoint and take ownership of issues. Resource Utilization: Skilled in identifying resources effectively to optimize outcomes. Self-directed: Able to work independently, demonstrating initiative and self-motivation. Software Development Lifecycle: Knowledge of the software development lifecycle (SDLC), from planning and development through to deployment and maintenance. Subject Matter Expertise: Exhibit a solid, hands-on understanding of the subject matter and systems supported. Technology Proficiency: Knowledge and effective use of relevant PC software applications and skills to use them effectively. Work Ethic: Strong work ethic characterized by dedication and reliability in team-based settings. .

Requisition ID: 33428 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient s life every second of every day and are committed to continuing to increase the number of patients we serve. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. We are seeking a skilled Maintenance Engineer with expertise in machine software, Electrical, Pneumatic and mechanical systems to oversee the maintenance, repair, and optimization of our equipment. The ideal candidate will have a strong background in software-controlled machinery and ensure maximum uptime and efficiency of production systems. Key Responsibilities: Maintenance Operations: Perform routine and preventive maintenance on machines and equipment to ensure optimal performance and reduce downtime. Troubleshooting: Diagnose and resolve mechanical, electrical, and software-related issues in production equipment. Software Management: Install, update, and configure machine control software, including PLCs, HMIs, VFDs and Servo drives. System Optimization: Analyze machine performance data to identify opportunities for efficiency improvements and implement changes. Documentation: Maintain accurate records of maintenance activities, including logs, reports, and software versioning. Compliance: Ensure all maintenance activities comply with safety, environmental, and quality standards. (GMP, ISO 9001, ISO13485, ISO14001, ISO45001) Collaboration: Work closely with production, quality, and engineering teams to address equipment issues and implement process improvements. Training: Provide technical support and training to operators and junior staff on equipment usage and software systems. Qualifications and Skills: Education: B tech in Electronics, Electrical, or Software Engineering, or a related field. Experience: 5+ years of experience as a Maintenance Engineer, preferably in a manufacturing or industrial setting. Technical Skills: Proficiency in PLC programming, CNC controls, and automation systems. Strong understanding of mechanical and electrical systems. Familiarity with software diagnostic tools and communication protocols (e.g., Modbus, Ethernet/IP). Ability to read and interpret technical drawings, schematics, and software logic diagrams. Soft Skills: Strong problem-solving and analytical skills. Excellent communication and teamwork abilities. Detail-oriented with a proactive approach to maintenance tasks. Certifications (Preferred): Electrical supervisory license. Work Environment: On-site in a manufacturing or industrial setting. May require occasional overtime or holiday shifts for urgent maintenance tasks. Exposure to machinery noise, moving equipment, and industrial environments. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect - Appreciative of others Integrity - Guided by our mission Care - Empathetic to patients Quality - Committed to excellence Creativity - Striving for innovation