Sr Eng Codes and Standards

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Summary:

A Systems engineering professional with experience in product systems architecture and systems level design product requirements management Traceability DHF structure & maintenance Compliance management plans requirements & testing Product Risk management System level integration and Verification & Validation of medical devices. This position may own & perform relevant Systems activities for the PSS and GSS products.

Essential Duties and Responsibilities:

Responsible for the coordination and development of the product systems architecture and systems level design including the decomposition of the system architecture and requirements into subsystem and interface specifications.

• 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.

• 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. Comeup 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.

• Interact with clinical and marketing to develop and refine user requirements.

• Communicate design requirements and provide technical guidance to suppliers as needed.

• Ensure user needs are captured quality requirements are met and technical risks are mitigated.

• Manage integration of deliverables from subsystem design teams and external partners.

• Identify and define high level requirements for a product or a feature that enhance the quality of therapy

• Identify and define high level requirements for a product or a feature that enhance the quality of therapy

• Plan and execute system integration activities to minimize issues in systems validation.

• Develop test plans test protocols and test reports for product integration testing.

• Document traceability from requirements to verification activities and from requirements to design entities.

• Resolve systemsrelated technical issues by applying problem solving tools such as cause and effect diagrams Pareto charts etc.

• Develop and maintain an effective and corroborative working relationship with internal and external development partners.

• Develop System requirements; propose architectures and connectivity specifications of medical devices with each other and with external medical systems.

• Ensure appropriate traceability between requirements interface specifications design and verification deliverables.

As Compliance Engineer:

• Coordination and management of standards compliance activities for assigned programs working with crossfunctional 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 (Hardware Mechanical Software) 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 crossfunctional partners including Regulatory team program management R&D teams manufacturing sites and service locations to develop comprehensive product certification and compliance strategies 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)

• Support the development System requirements and drive the cascade of the requirements to hardware and software subsystem requirements.

• Ensure appropriate traceability between requirements interface specifications design and verification deliverables.

• Identify compliance risks and reliability related requirements from applicable product standards (collateral and particular).

• Collaborate with crossfunctional resources (e.g. hardware clinical human factors etc. involved in designing for Compliance and ensure designs provide adequate margins.

• Support sustaining teams in EMC investigation and identification of root causes.

Qualifications:

• Must possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines Electromechanical Systems Fluid Mechanics Materials Sciences

• A demonstrated track record in electromechanical system development preferably medical devices or other highly regulated products.

• Strong team player able to meet deadlines and handle changing priorities.

• Experience in resolving complex technical problems using strong analytical skills.

• Excellent written oral and interpersonal skills

• Must be proficient at time management and multitasking.

As Compliance Engineer:

• Knowledge of medical device requirements for Global (US Canada Europe Korea Japan Australia/New Zealand Latin America Caribbean MEA)

• Knowledge and Hands on experience on all EMI/EMC standards/tests and knowledge of EMC regulations and certification procedures applicable to Medical Devices globally including testing documentation certification requirements and procedures (i.e. IEC/EN60601 CISPR 11 FCC EU IC etc..

• Hands on experience on Safety standards (IEC 60601 series) including collateral and particular standards

• In depth knowledge on wireless regulations and standards (ETSI series FCC IC RED (Radio equipment directives) for medical products

• Familiarity with regulatory requirements of FDA and EU MDR.

• Ability to perform diagnostics and correct EMC failures in conjunction with design engineers

• Strong electronics background is essential

• Strong experience in Requirements Management Configuration Management Defect Tracking and Traceability

• Experience with EMC design tools automated EMC testing tools electronic test equipment (scopes logic analyzers)

• Knowledge of FDAs guidance on design controls and software validation as well as ANSI/IEEE standards for EMC engineering

• Demonstrated experience interfacing with regulatory agencies conformity assessment bodies (UL Intertek CSA etc. and standards development organizations (IEC ISO NEMA NFPA ETSI etc..

Reasonable Accommodations

Baxter 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.

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