Job Description

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission. About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis sterile IV solutions infusion systems and devices parenteral nutrition surgery products and anesthetics and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Position Overview You will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for our new and existing dialysis product portfolio. The successful candidate will possess solid 'hands-on' technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. Essential Duties and Responsibilities Work with design engineers for development of product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans and product compliance strategy, Participate in design and development activities including design review, and partner to resolve EMC and product safety issues Engage with program teams on product certification strategy and compliance issues Ensure compliance of Baxter Healthcare hardware solutions with global standards requirements. Will also support efforts to comply with global environmental regulations. Interact with program management, R&D teams, manufacturing sites and service locations to ensure that Baxter Healthcare solutions comply with product certification requirements in the intended use markets (domestic and international). Defines test protocols and conduct the necessary testing required to verify/validate the quality, safety and performance of the design(s). Maintain quality records in line with the quality system requirements. Develops and maintains an effective and corroborative working relationship with internal and external development partners. Creates and communicates design/test plans, tasks, deliverables, and status. Manages time and resources to meet committed schedule milestones. Ensure that all compliance test equipment complies with the test requirements specified in compliance standards. Schedule compliance testing for Baxter Healthcare products at onsite test facility and at external test laboratories. Support in house pre- compliance/evaluation testing and ensure compliance test equipment is well Keep abreast of changes to product standards and regulations affecting medical products. Engage in developing global roadmaps for standards in a particular contact area. Occasional travel may be required to perform job duties. Participate in developing standards strategy for Baxter programs that enable market access of medical devices in the intended markets for product. Participate as a Baxter representative in Standards committees Manage and maintain relationships with certifying bodies and certification test houses. Qualifications B.S.in Engineering and 8+ years related experience, or M.S. in Engineering and 5-6 years related experience. Must have successful and progressive experience in safety design engineering international design safety standards knowledge required. Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Effectively operate in and may facilitate cross-functional teams across global sites. Must be able to provide solutions that reflect understanding business objectives and cost implications. A Career That Matters Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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 . 080190