Principal Engineer, Acute Disposables

Job Description

Principal Engineer, Acute DisposablesApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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 BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre 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.Job Description Responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. Independently drive/contribute to the Projects/Initiatives involving Engineering change management, solutions for Product quality issues, root cause analysis, NCR handling, CAPAs, verification & validation, design transfer, Value improvement programs and Regulatory compliance activities. Contribute to the development of new functions/features to be integrated into the existing products/new products.Essential Duties and Responsibilities:
• Leads the R&D activities of Disposables on assigned projects.
• Thorough understanding and drives application of phases of life cycle management
• Ability to apply life cycle management principles within exploratory, new product development or sustaining phases
• Can perform as an independent reviewer in technical and design reviews
• Leverage knowledge of technology, process, and/or therapy domains to drive solutions and product design realization.
• Demonstrates understanding of and adherence to FDA, ISO [13485 & 14971] and IEC design control procedures, regulations and standards within area of responsibility/expertise
• Contributes to the program/project or the organization s technical strategy.
• 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.
• Responsible for preparation of project cost estimates and monitor all project expenditures and cost tracking
• Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.
• Organizes and presents technical project management overviews without assistance. Oral and written communication is well planned, organized and has a clear logical flow.
• Ensures successful integration of disposables design elements into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the engineering and design 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. Ensures Systems that are optimized for production, reliability, regulatory compliance, and cost.
• Provides leadership to effectively transition products to manufacturing and ensure robust products and manufacturing processes.
• Performs in-depth mechanical engineering analysis and calculations.
• Manages integration of deliverables from sub-system design teams and external partners.
• Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s). Develop test plans, test protocols, and test reports for product integration testing, also develops the infra required for the testing.
• Adheres to Baxter Quality Management system and support audits and external inspections as applicable.
Education and Experience
• Graduate or Postgraduate in Mechanical Engineering/Bio Medical engineering or Equivalent.
• Minimum 8 years of R&D experience in New product development/Sustenance.
• Prior experience of Medical Device Risk management activities.
• A proven track record of management/leadership effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.
A Career That MattersBaxter s employees are united in a mission to save and sustain lives. We are passionate about applying scientificinnovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies andtechnologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuingcreative collaborations that bring our mission to life for patients every day.Equal Employment OpportunityBaxter 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 AccommodationsBaxter 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 Americas_TTA@baxter.com 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 Recruitment Fraud Notice . 105545Apply Now Save Job,

Keyskills :
javalinuxjavascriptframeworkbill of materialsroot cause analysisnew product developmentengineering change managementcontinuous improvement facilitationquality management systemlife cycleroot causeproject coststudy reportsproduct designdes