Senior Engineer - Systems V&V

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Summary

Apply a solid understanding of System engineering practices and theories/practices in Risk Management toward the development of new or enhanced products or processes.  Support the advancement of Risk and Reliability competencies and execution across the Device Systems Engineering organization.

Essential Duties and Responsibilities:

• Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance. 
• Identify and define high level requirements for a product or a feature that enhance the quality of therapy
• 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.
• Identify and define risk and reliability related requirements from applicable product standards (collateral and particular).
• Provide leadership and coaching to design teams in Risk process execution using relevant methodologies, tools, and techniques.
• Lead and coach design teams in the development/maintenance of Risk planning and deliverables aligned with Baxter Global Risk Management procedures.
• Collaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in Risk Management and Reliability process activities.
• Support sustaining teams in investigation of Risk and Reliability issues.
• Lead teams through credibility and influence.

Qualifications:

• B.S.in Mechanical Engineering, Electrical Engineering with minimum 6-12 years of hands-on experience in Product Design and development, and fluent in full life-cycle product development methods/activities, preferably in a regulated industry.
• Must possess engineering knowledge and product development experience in relevant electromechanical disciplines, preferably Medical Devices.
• Working knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).
• Solid understanding and application of the standards related to Risk Management: (e.g., ISO 14971, IEC 61025, IEC 62366, IEC 60601, ISO 13485 etc.).
• Demonstrated experience in creation of typical failure analysis deliverables at different levels of product (Hazards Analysis, FMEAs, FTAs, etc.).
• Experienced in handling customer complaints, performed the root-cause analysis in investigations and resolve them as part of engineering team
• Expertise and fluency in Excel, Minitab, Doors, and other Requirements Management & Risk tools.
• Strong critical thinking skills.
• Requires strong organization and polished communication skills (both written and oral), with the ability to interface with both technical and non-technical personnel throughout the organization.
• Able to work independently or with a cross-functional team in a fast-paced environment.
• Able to lead multiple projects and work across organization boundaries.

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, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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