Sr. Principal Engr, Compliance

Job Description

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.Responsible for delivering R&D programs, leading the efforts in the coordination and management of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
• Have clear Understanding of Unmet Needs, define scope, Use-cases driven system requirements by Prioritizing feature, and identifying dependencies & inadequacies for different products such as Infusion pumps and its accessories
• Be a Liaison between Marketing, Clinical, Regulatory, Serviceability, HW/SW, Risks and Cybersecurity
• Drive decisions through ambiguous situations by Understanding the big picture, Challenges in realizing the feature, resolve conflicts and negotiate between upstream and downstream teams.
• Conduct Market Research, Driving Digital Initiatives and Competitive benchmarking through defined framework
• Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
• Thorough understanding and drives application of phases of life cycle management.
• Ability to apply life cycle management principles across all phases of life cycle management.
• Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the requirements 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.
• Understands clinical and user needs and can apply to product realization. Creates and maintains Design History File elements.
• Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.
• Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards.
• Can perform as an independent reviewer in technical and design reviews.
• Establishes, maintains and actively develops associations with cross functional business partners and/or functional peers across Baxter.
• Utilizes creative thinking and teamwork to resolve conflicts.
• Makes proficient and disciplined critical decisions and systems deliverables (e.g. program milestones, technical design reviews).
• Embraces team and management decisions while also raising issues to appropriate level.
• Identify and define high level requirements for a product or a feature that enhance the quality of therapy
• Will work with Risk and Compliance Manager within Medication Delivery to ensure compliance of product solutions with global standards requirements. Will also support efforts to comply with global environmental regulations.
• Expedite, manage, and coordinate interrelated systems 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 systems engineering.
• Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.
• Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.
• Successfully influences stakeholders and cross-functional team members within the project.
• Initiates, develops and leads technical feasibility analysis for product or subsystems; translates customer/user needs to product needs.
• Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope.
• Teaches and mentors others in life cycle management methodologies.
• Lead teams through credibility and influence.
• Coordinates efforts of cross functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
• Ensures cross-functional review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional, program and/or project team to make decisions.
• Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
• Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing) required to deliver products to market.
• Works with Project Management to create and manage schedules for systems and sub-systems.
• Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance
As Compliance lead:
• Coordination and management of standards compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products.
• Partner with design engineers to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, compliance and safety issues.
• Consult with program teams on product certification strategy and compliance issues where needed
• Facilitate and coordinate input from multiple cross-functional partners including Regulatory team, program management, R&D teams, manufacturing sites and service locations to develop comprehensive product certification and compliance strategies, develop and maintain therapy area compliance roadmaps and dashboards, and ensure that Baxter Healthcare solutions comply with product certification requirements in the intended use markets
• Keep abreast of changes to product standards and regulations affecting medical products.
• 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. Manage product test and certification projects with onsite and external test laboratories.
• Prepare standards test reports and other documentation in accordance with applicable regulations.
• Submit documentation to regulatory authorities as required to obtain product certifications for different global regions (e.g. US, Canada, Europe, Korea, Japan, Australia/New Zealand, Latin America, Caribbean, MEA)
• Ensure that lab test procedures and compliance process comply with Baxter Healthcare policies, and international standards and quality management requirements.
• Will work under the direction of the Product Certification Manager to ensure compliance of Baxter Healthcare hardware solutions with standards requirements. Will also support efforts to comply with environmental regulations.
• Support Baxter Healthcare organizations located throughout the world in their efforts to obtain product certifications approvals
• Ensure compliance test equipment is well maintained and calibrated in accordance with international requirements.
• Develop standards strategy for Baxter programs that enable market access of medical devices in the intended markets for products. Participate as a Baxter representative in Standards committees. Manage and maintain relationships with certifying bodies and certification test houses good to have
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Keyskills :
market accessproduct design