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. Description As Principal Engineer, guide technical team members in the application of systems engineering and systems connectivity concepts to the integration of medical devices with external medical systems. Resolve difficult problems, from conception to final design with team input. Plans and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures, and criteria with minimal guidance. Contributes to a Systems Engineering vision that aligns with the organization's vision and strategic plan. Utilizes solid understanding of device and system connectivity concepts in a medical device domain. Provides direction to technical team members that are accountable for implementing integration and connectivity deliverables. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.
Essential Duties and Responsibilities
- Create system requirements, architectures and interface specifications to allow the connectivity of medical devices with external medical systems
- Collaborate with design partners, either internal or external to Baxter, to determine needed functionality, allocation of functionality to different systems and the specifications of the interfaces between the systems.
- Analyzing existing external systems for the potential of integrating with Baxter medical devices; identifying the potential benefits or areas for improvement in such integrations.
- Collaborate with functional teams, such as software, to realize system deliverables in functional deliverables, such as software requirements and software design.
- Create and execute verification activities of system deliverables as well as verification of the overall integration between medical devices and external medical systems.
- Ensure appropriate traceability between requirements, interface specifications, design and verification deliverables.
- Primary technical contact between Baxter and selected external design partners.
- Deep expertise with medical devices, electronic medical record systems and other medical systems resident in the hospital environment.
- Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Clinical, Human Factors, Regulatory, Marketing, Service)
- Directing internal resources as well as potential contractors and/or 3rd party service providers.
- Ensure compliance to the product development process and Quality System and Design Control requirements.
- Familiarity with IHE and HL7 specifically in the PCD domain.
Qualifications for this role
- Experience with medical devices and medical information systems.
- Experience in developing systems engineering deliverables such as requirements, architecture and verification plans / tests / reports.
- Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel.
- Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
- Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
- Effectively operate in and may facilitate cross-functional teams with guidance.
- Must be able to provide solutions that reflect understanding business objectives and cost implications.
Education and Experience B.S. in Engineering preferred and 5 - 8 years related experience, or M.S. and 2- 4 years related experience. Ph.D. 1 - 2 years experience.