As a member of cross-functional team, integrates cross functional inputs to delivery of a project of minor to moderate complexity. Product Requirements creation, analysis and management. System integration and testing. Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization. Contributes through demonstrated hands-on participation with teams. Accountable for direct production of project deliverables. Contributes to design concepts and research methodologies that meet current and future customer & business needs for a product or process domain area. Participates as a member of Design Review Teams. Ensures inclusion of inputs into product and technical design reviews from cross functional stakeholders. Proposes and drives solutions to technical problems. Engaged within the team. May act as the leader for a subsystem for products of minor to moderate complexity or as a subject matter expert on technical problems. Understands and contributes to resolution of competing constraints within assigned function (e.g. systems, electrical, software, or mechanical engineering) required to deliver products to market. Able to apply technical risk mitigation tools and execute mitigation strategies to ensure optimal results. Able to contribute to the program/project or the organizations technical strategy Role & responsibilities Preferred candidate profile
Role & responsibilities Leads the evaluation and development of Disposables on assigned projects with focus on risk management. Owns and maintains the risk management files for the assigned product families. Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones. Collaborates with cross functional team (e.g., Quality, regulatory, clinical) to ensure the proper deployment of risk management activities. Manages and prioritizes multiple projects and tasks. Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques. Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management. Organizes and presents solutions from risk management perspective without assistance. Oral and written communication is well planned, organized and has a clear logical flow. Ensures successful integration of disposables design elements from risk management perspective into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the risk management tasks. Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing ensuring acceptable risk profile of the device is maintained throughout the entire product lifecycle. Support, from risk management perspective, the necessary testing required to validate the safety and effectiveness of the design(s). Preferred candidate profile Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent Minimum of 6 years of relevant experience, Prior experience of technical leadership in Sustenance/New product development in Critical care Medical device domain is a plus. Experience in a regulated industry preferably medical devices and familiarity with ISO 13485, and ISO 14971 Qualifications Proficiency with MS Office and other office productivity tools. Self-directed, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Strong hands-on lab skills, and prototype fabrication skills. Very adept at grasping and solving complex problems using root-cause analysis techniques. Previous experience on product risk management is a plus. Ability to objectively identify technical solutions, and make sound engineering decisions. Clear and effective communication (written and oral) and presentation skills. A proven track record of effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables.
As Manager, Systems Engineering of Peritoneal dialysis department within Renal business, expected to deliver to the department vision that aligns with the organization's vision or strategic plan. Based on significant technical expertise, reviews and approves complex design concepts and provides general direction to technical staff. Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Acknowledged outside of business unit or division for input on programs of some magnitude. Exhibits creativity and innovation in completing divisional and cross-functional/business unit responsibilities. Role & responsibilities : Effectively communicate and realize vision and strategy for the organization that aligns with the business and patient needs. Ability to lead technical team in the group that ensures clear accountability and operational excellence. Ensures that succession planning and talent pipeline is in place for the team members across multiple functions and/or technical disciplines. Leverage partnerships effectively with cross functional teams including the business unit, quality, program management, manufacturing, regulatory, medical and clinical to achieve business results. Establish processes for effective resource management from planning through execution in close collaboration with program management. Foster an environment where mentoring, coaching, career growth and progression, and employee development are critical focus areas. Create a culture and environment that attracts, develops, retains, and grows diverse and top talent aligned with organizational strategy. Ensure effective performance management. Applies knowledge of medical device lifecycle management to effectively drive specific phases of product development and sustainability with high quality and predictability of timeline and budget. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards and ensures appropriate design controls are being adhered to during sustaining engineering efforts and new product development. Takes ownership for the continuous improvement initiatives within the assigned function in alignment with business needs. Identifies and builds technical competencies and system approach to realize all aspects of product development including innovation/ideation. Drives effective collaboration with external partners. Lead the development and integration of project System deliverables which may cross several disciplines; evaluate alternatives against agreed criteria. Coach the team to select solutions, assess risks and for understanding full range of implications across the system. Review and analyze proposals to determine if benefits derived and possible applications meet quality, cost and performance with future roadmap and sustenance considered. Qualifications / Experience and/or Background Bachelors in Electronics or Electrical or Mechanical Engineering or Computer Science or any other relevant engineering discipline, Masters preferred, 12+ years of experience including 2+ yrs of functional leadership experience. Must be well versed in engineering disciplines Must possess knowledge of related disciplines. Knowledge of GMPs, FDA guidelines, purchasing practices and process validation. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience. Ability to manage multiple cross-functional teams simultaneously. Ability to design and influence outside of immediate scope of responsibility. Maintain industry contacts and be involved in industry interest groups. Proven track record of management/leadership effectiveness
SUMMARY : This position owns & performs the System Requirements and Risk management activities for either a new product under development or a family of dialysis devices as they are used in dialysis therapy, in accordance with the regulatory standards (main being ISO 14971) & requirements. Roles & Responsibilities: As a member of cross-functional team, integrates cross functional inputs to delivery of a project of minor to moderate complexity Responsible for performing the activities associated with the System Requirements and Risk Management of one or more products in various stages of the product lifecycle from new product development to post market surveillance. Understands the user needs, derives the system requirements, authors the same, reviews with cross functional teams and maintains the same for any changes and traceability. Flows down the same to sub system requirements working with sub system teams. Performs risk assessment on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation. Come-up with the recommended mitigation with the rationale. Ensure that no unacceptable risk goes undetected and unmitigated. Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities. Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management. Facilitate an improved understanding of the interrelationship between Risk and Reliability. Working knowledge of FMEAs and standards applicable to Reliability Engineering. Provides subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle. Leads Risk Management activities in coordination with other cross-functions like HW, SW, HF, Collaborates with Engineering, Manufacturing and Service organizations in the development of design FMEA, Process FMEAs and roll-up into Risk Management files. Creates and approves Design History File deliverables associated with Risk Management. Provides ongoing risk analysis and identification of required risk mitigations to ensure safe, effective product. Able to analyze risk/tradeoffs and make recommendations of appropriate path forward. Successfully influences stakeholders and cross-functional team members within the project. Education, Experience & key attributes: Graduate degree in Engineering, with a minimum of 8 years of practical Electromechanical Medical Device Design experience, some of which is in Requirement and Risk management. Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project. Sound knowledge identifying, authoring system requirements derived from user needs Sound knowledge of Risk management standard ISO 14971 and its application. Good understanding of medical device QMS ISO 13485 with experience of having worked in this environment. Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation. Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.) Requires a high level of independence and excellent interpersonal and communication skills. Able to prepare and make written and verbal presentations to cross-functional audiences as required. Team player Six Sigma Green belt or Black Belt (DFSS) certification preferred. Role & responsibilities Preferred candidate profile
Job Description The Engineering Project Leader works with people around the world to support our global installed product base. In this role you will lead several Product Design Change initiatives for Vantives global Acute, PD and HD Therapies products. You will be expected to manage Design Change Projects from proposed initiative inception to final production implementation and market rollout. Job Responsibilities: Create the project plans including objective, scope, execution path, assumption, risk, schedule and resource needs Deploy metric-based project tracking Facilitate regular team meetings to set and manage work assignments Communicate project progress to global stakeholders Identify, mitigate, and manage project and technical risks following risk management processes Lead and participate in the development of project strategies and reliable technical solutions that meet requirements and inputs Hold responsibility for design control documentation Execute engineering change control efforts per established processes and manage the deliverables per QMS requirements Coordinate design change implementation in production and into markets Qualifications & Skills Previous Sustaining Engineering and Project Management experience with demonstrated success leading multi-site activities in the medical products industry Strong product development background having led the development or participated in at least one complete medical device product development project end to end, i.e. from concept to production launch Participated in at least one electromechanical design project Strong Communication Skills Enthusiastic, must be self-driven Metric Focused, understands incremental delivery and the value of metrics Education/ Experience: Strong engineering background with at least a technical bachelors degree (Electrical, Mechanical or Systems Engineering). Minimum of 2 of years’ experience in project or program management, and 3 years of experience in medical devices Hands-on experience using Product Lifecycle Management (PLM) Tools Project Management knowledge including Agile methodologies, preferably with current certificationRole & responsibilities Preferred candidate profile
DevOps Engineer Job Description Responsibilities Develop deployment scripts and drive deployments for mission critical applications Drive productivity with focus on automation and continuous improvement. Responsible and accountable for production release deployments Implement continuous integration solutions to perform comprehensive review of source code during software development. Implement continuous integration solutions to package software and deploy on device boards. Qualify continuous integration tools and build/release process and release documentation. Working with cross functional team members to identify, document and implement CI solutions. Form partnership with team and balance uneven workloads across team to hit key project milestones. Drive efficiency and standardization in tools and techniques. Identify industry best practices/solutions and pursue continuous improvement opportunities in SDLC (Software Development Life Cycle) processes and practices, relentlessly drive for standardization, automation and self-services Skills & Qualifications Devops Engineer with medical device exposure is desired, applicants with job history in other discipline are invited to apply with below requirements are meet. General: 6+ Overall experience, 4+ Devops experience. Bachelors Degree required. Must demonstrate the ability to prioritize and organize work. Excellent communication and interpersonal skills, ability work in agile and multiple team organization. Passionate about continuous learning and keeping up with latest technologies. Proficiency in DevOps methodologies, tools (Jenkins, Git), processes and culture. Experience in DevSecOps tools and integration of SecOps tools in CI – SAST, SCA and DAST Experience in Embedded development framework: Windows based IAR workbench and linux based Yocto distribution System. Proficiency in scripts and automation using Python/Groovy/powershell/Bash Proficiency with Cloud Environment (AWS, Azure) Proficient in Linux (Redhat, Centos, or Ubuntu) system administration, fluent with shell scripting Working knowledge of networking, security and virtualization Experience with subnetting Experience with Active Directory Experience with AWS Cloud (EC2,S3.CFT.ELB,EKS,Lambda,CloudWatch,CloudTrail,EKS,ECS,ECR,Redshift,KMS,IAM) Experience with domain controller and DNS server configuration Experience configuring various hardware and software firewalls Experience with Linux (RedHat, Centos, or Ubuntu) Experience with Serverless Technologies on AWS : Lambda, API Gateway, S3 Experience with administering Apache, Tomcat, Oracle and IBM MQ Servers Experience with package managers (e.g., apt, yum, Homebrew) Experience in development of utilities using Shell, JSON and YAML scripting to automate processes Experience with Bash and PowerShell scripting Experience with coding with Python (Testing and Automation) Experience with runtime configuration management tools: Like: Chef, Ansible, CloudFormation, Packer, CodeBuild , CodePipeline Experience with CI/CD tools: Like: Jenkins, Ant, Git WebHooks, Artifactory Experience with containerization, Docker, Kubernetes architecture, and CI/CD DevOps with Kubernetes Experience with managed Kubernetes (AKS, EKS, GKE, OpenShift) across multiple Cloud providers like AWS, Azure and GCP. Experience with Kubernetes Cluster Security like RBAC, Network Security etc Experience on different K8s deployment patterns Experience with project management tool like JIRA, ServiceNow Experience with Change management Experience with Team managements Skills Role & responsibilities
Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. JOB TITLE: Senior Specialist, HR JOB LOCATION: Bengaluru, Whitefield Job Description Summary The role is an enabler for HR Business Partners at Vantive as part of the global organization and supports the business who is an innovator in kidney care, offering leading solutions for peritoneal dialysis, hemodialysis, and organ support therapies, including continuous renal replacement therapy (CRRT) while working alongside HR Center of Excellence (COE) functions. Role and Responsibilities In this role, the incumbent will be accountable for owning and driving following initiatives at the site: People Onboarding and Induction for lateral and campus hires Exit Management and offboarding Prepare payroll inputs for HR Operations Coupa & Vendor management for all payments and procurement for HR team Workday data management (HRMS)- Maintain the data accurately and assist managers/ employees with queries and share reports Management Information System (monthly)- Leverage data and analytics to bring out business insights Administer Rewards & Recognition program Coordinate workshops/ training programs Compliance Management- Site audits and training assignment Participate in deploying HR projects and programs Be a steward for employee experience- Coordinate for activities/ initiatives for culture building and delivering high-impact HR programs. Monitor the effectiveness of HR programs and initiatives and make recommendations for future improvement. Collaborate with HR Center of Excellence (COE) and other partners to implement HR solutions that address business needs and deliver on business imperatives. Qualifications Bachelor’s / Master’s degree in Human Resources or equivalent field 5+ years of relevant experience Experience of working in Engineering/ Technology organizations or related industry is preferable Ability to thrive in a fast-paced, dynamic environment with frequent changes Excellent communication skills and ability to manage stakeholders in a diverse/ global setting Strong collaborator Fluency in technology and data interpretation Proficient in MS suite-PowerPoint/Excel/Power BI, and HRMS like workday If you are a result-oriented HR professional with a passion for making a difference in the lives of others, we encourage you to apply for this exciting opportunity.
Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. JOB TITLE: Manager, HR JOB LOCATION: Bengaluru, Whitefield Job Description Summary The HR Business Partner role at Vantive is a part of the global organization and provides expertise, counsel, and partnership on a variety of HR areas to the business. In this role you will partner with the business who is an innovator in kidney care, offering leading solutions for peritoneal dialysis, hemodialysis, and organ support therapies, including continuous renal replacement therapy (CRRT). You will work as a strategic advisor to business leaders on all matters relating to people’s lifecycle from hire to exit. You will support key priorities with the forward-looking people agenda and will be a champion of delivering exceptional people experience. You will work alongside Kidney Care business leaders in R&D and partner with Managers and employees to enable team and individual effectiveness. Roles and Responsibilities Provide advice and guidance to business leaders on all people-related matters, including talent acquisition, performance management, talent review, succession planning, career development and employee relations. Implement people strategy and initiatives to drive high-performing culture and build inclusion and belonging at workplace. Partner with business leaders to deliver high-impact HR programs and initiatives. Be a steward of employee experience, and develop, deploy, and champion best-in-class processes, frameworks, and programs that make Vantive in India a great place to work. Educate, influence, and advocate reward and recognition philosophy and practice within the business to ensure fairness and consistency and inspire stronger people and organizational performance. Partner with business to identify training needs at employee, department, and organization level. Translate trends from engagement/pulse surveys into leadership and culture insights to enable actionable plans for driving organization effectiveness. Monitor the effectiveness of HR programs and initiatives and make recommendations for future improvement. Leverage data to provide insights to relevant stakeholders for decision making. Participate/lead, execute, and deploy HR projects and programs (both global and local). Understand employee grievances and disputes, and partner with Ethics & Compliance and Legal teams to advise and initiate appropriate employee disciplinary actions. Collaborate with HR Centers of Excellence (COE) and other partners to implement HR solutions that address business needs and deliver on business imperatives. Qualifications Master’s degree in Human Resources or equivalent field. 12+ years of relevant experience. Experience in Med Tech/ Engineering organization or related industry is preferable. Ability to thrive in a fast-paced, dynamic environment with frequent changes. Ability to deal with ambiguity and manage conflicts. Excellent communication skills, learning agility and stakeholder management in a diverse/ global setting. Strong business acumen and collaborator. Fluency in technology and data interpretation. Proficient in MS suite-PowerPoint/Excel, and HRMS like workday. If you are a strategic and result-oriented HR professional with a passion for making a difference in the lives of others, we encourage you to apply for this exciting opportunity.
DevOps Engineer Job Description Responsibilities Develop deployment scripts and drive deployments for mission critical applications Drive productivity with focus on automation and continuous improvement. Responsible and accountable for production release deployments Implement continuous integration solutions to perform comprehensive review of source code during software development. Implement continuous integration solutions to package software and deploy on device boards. Qualify continuous integration tools and build/release process and release documentation. Working with cross functional team members to identify, document and implement CI solutions. Form partnership with team and balance uneven workloads across team to hit key project milestones. Drive efficiency and standardization in tools and techniques. Identify industry best practices/solutions and pursue continuous improvement opportunities in SDLC (Software Development Life Cycle) processes and practices, relentlessly drive for standardization, automation and self-services Skills & Qualifications Devops Engineer with medical device exposure is desired, applicants with job history in other discipline are invited to apply with below requirements are meet. General: 6+ Overall experience, 4+ Devops experience. Bachelors Degree required. Must demonstrate the ability to prioritize and organize work. Excellent communication and interpersonal skills, ability work in agile and multiple team organization. Passionate about continuous learning and keeping up with latest technologies. Proficiency in DevOps methodologies, tools (Jenkins, Git), processes and culture. Experience in DevSecOps tools and integration of SecOps tools in CI – SAST, SCA and DAST Experience in Embedded development framework: Windows based IAR workbench and linux based Yocto distribution System. Proficiency in scripts and automation using Python/Groovy/powershell/Bash Proficiency with Cloud Environment (AWS, Azure) Proficient in Linux (Redhat, Centos, or Ubuntu) system administration, fluent with shell scripting Working knowledge of networking, security and virtualization Experience with subnetting Experience with Active Directory Experience with AWS Cloud (EC2,S3.CFT.ELB,EKS,Lambda,CloudWatch,CloudTrail,EKS,ECS,ECR,Redshift,KMS,IAM) Experience with domain controller and DNS server configuration Experience configuring various hardware and software firewalls Experience with Linux (RedHat, Centos, or Ubuntu) Experience with Serverless Technologies on AWS : Lambda, API Gateway, S3 Experience with administering Apache, Tomcat, Oracle and IBM MQ Servers Experience with package managers (e.g., apt, yum, Homebrew) Experience in development of utilities using Shell, JSON and YAML scripting to automate processes Experience with Bash and PowerShell scripting Experience with coding with Python (Testing and Automation) Experience with runtime configuration management tools: Like: Chef, Ansible, CloudFormation, Packer, CodeBuild , CodePipeline Experience with CI/CD tools: Like: Jenkins, Ant, Git WebHooks, Artifactory Experience with containerization, Docker, Kubernetes architecture, and CI/CD DevOps with Kubernetes Experience with managed Kubernetes (AKS, EKS, GKE, OpenShift) across multiple Cloud providers like AWS, Azure and GCP. Experience with Kubernetes Cluster Security like RBAC, Network Security etc Experience on different K8s deployment patterns Experience with project management tool like JIRA, ServiceNow Experience with Change management Experience with Team managements Skills
Main Duties and Responsibilities: Under supervision of the Manager HR by following appropriate instruction and training, carry out the following tasks: Manage Onboarding and Induction Process of the Organization Employment Letters preparation, Collect statutory forms and document it. Share Insurance Data with Vendor and conduct the session to employees Co-ordinate with C& B and prepare Induction for New Joinees Manage and Update Personal Files and Other databases and scanning and documenting of the employment contracts. Manage the Statutory Compliance activity for the Organization Manage the Apprentice Program for the Organization-Monthly and quarterly Program Prepare and the statutory registers and different Labor laws. Obtained New Labor license and amended the exiting License (S&E and CLRA etc) Monthly Data sharing with Vendor Display and Notice Board Management Manage All Provident fund organizations related application and status Coordinate with vendor and Employees Reports Preparation and sharing with stakeholders. Support organization and employees by preparing and Release the Following Letters as and when required Promotion Letters Designation changes letters Salary change Letters VISA letters Experience Letters Reliving Letters Support organization managing HR Vendors Management Coordinate with Legal team to prepare new contracts Update/ extend current Contracts Generate the Purchase orders Invoice Verification and Process. Exit Process No due Collection from Employee and Departments Release reliving and Experience Letters. Preferred candidate profile