Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years our team has driven meaningful innovations in kidney care As we build on our legacy we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams and longer fuller lives for patients that is what Vantive aspires to deliver 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 don t settle for the mediocre Each of us is driven to help improve patients lives worldwide Join us in advancing our mission to extend lives and expand possibilities The Hardware Director is responsible for all Hardware R D activities related to all Electro-Mechanical Devices and Platforms and their integration with Systems and Software for the company This includes Feasibility Prototyping New Product Development NPD Sustaining phases of the product development lifecycle and establishing common tools Processes across the Global product portfolio Director will lead a global team of Hardware leaders including technical and functional leaders spanning architecture design and development Hardware testing Reliability across technology products and provides functional expertise and guidance The role needs to utilize a solid understanding of theories and practices of a variety of disciplines to help manage complex projects or programs within boundaries of Scope Schedule and the Budget Director will be a key member of the business R D Leadership Team responsible for creating and implementing department vision that aligns with the organization s vision and strategic plan They will co-lead and collaborate on several strategic initiatives with Systems Supply chain Manufacturing Program Management Office PMO Margin Improvement Programs MIP initiatives Quality and Regulatory functions The role will also be accountable for driving specific operational efficiency driving the activities consistently with business objectives to position organization for the future serving as engineering representative of the company with internal customers to coordinate all development efforts Essential Duties and Responsibilities Business Manages the Hardware global organization for the Peritoneal Dialysis PD Hemo-Dialysis HD Water Systems and Acute Therapies establishing clarity of ownership across Global sites and augmenting support where needed Understands customer patient therapy needs and product roadmaps for the business Leads the strategic planning and technical roadmap development and is accountable for the execution of Exploratory New Product Development NPD Sustenance Margin Improvement Programs MIP spanning across the Vantive Electro-mechanical product portfolio Create effectively communicate and realize vision and strategy for the organization that aligns with the business and patient needs Drives continuous improvement initiatives across the Global Hardware Function in alignment with business needs Organization Identifies and builds strategic technical competencies in the R D organization to realize all aspects of the business product development needs Provide strategic planning leadership for resource staffing and project execution with proactive management of technical and project risk to ensure delivery of business commitments Establish an organization structure that ensures clear accountability and operational excellence Ensures that the succession planning and talent pipeline are in place Creating a culture and environment that attracts develops retains and grows diverse and top talent aligned through an environment of mentoring coaching career growth and progression and employee development are critical focus areas Fosters an environment where mentoring coaching career growth and progression and employee development are critical focus areas Embraces the agile ways of working in support of a fail-fast-learn-fast culture and enabling continual improvement Foster a collaborative work environment with strong working relationships within and across businesses and functions and with strategic external partners Understanding of Global regulatory requirements International Healthcare standards for medical devices risk and reliability concepts for development and associated quality processes Continuously improves the functional efficiencies sharing the best practices lessons learnt across product streams to deliver best-in-class development output and optimize fiscal funding Work towards simplification efforts of having common tools common component libraries across the company Addresses proactive obsolescence Management - working in close collaboration with Supply chain and adapting state of art Industry practices Leverages and support cross functional teams including Sustaining engineering the larger business unit quality program management manufacturing regulatory medical and clinical to achieve business results Maintains the current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development product development design and safety to ensure compliance in all research data collection and reporting activities Program Product Accountability Effectively manages resources from planning through execution in close collaboration with Program management Applies knowledge of medical device lifecycle management to effectively drive specific phases of product development with high quality and predictability of timeline and budget Adheres to FDA ISO and IEC design control procedures regulations and standards and ensures appropriate design controls and are being adhered to Ensure business needs regarding product reliability and cost targets are realized as part of product requirements and ensure effective application of DFx FMEA risk management practices Qualifications Strong Experience across product functions spanning Systems Engineering Hardware Engineering in Healthcare and other industrial Electro-mechanical devices Adept experience leading a cross functional team and working in a global matrix workplace Strong team building and talent management skills and the ability to motivate the team to achieve their goals Proven experience in driving product specific and overall portfolio strategy in a global business Must possess strong knowledge of scientific technical disciplines and solid knowledge of related disciplines such as regulatory quality and or product development Must be a strategic innovative problem solver and have strong influencing and communication skills Education and or Experience Graduate or Post-Graduate in Electronics Mechanical Engineering streams 20 years of overall industry experience at least 15 years of functional Leadership experience in healthcare industry and 5 years of Global functional Leadership experience Prior experience of managing an Electro-mechanical function globally with multiple Senior Managers in their current role Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams where fraudulent parties pose as Vantive employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and or financial information To learn how you can protect yourself review our Recruitment Fraud Notice