Vantive Healthcare Technologies

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