Product Risk Management Owner M/F

This is where you save and sustain lives

At 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. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s 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.

Summary

As a Product Risk Management Owner (PRMO), the incumbent works as part of a team and performs work in Risk Management through application of standard techniques, procedures, and criteria, with high focus in Engineering for Renal Care Solutions used in HD Therapy.

Essential Duties and Responsibilities.Oversee Risk Management activities of the HD Solutions products.

• Support design teams in risk process execution using relevant methodologies, tools, and techniques in the development/maintenance of Risk planning and deliverables.
• Collaborate with cross-functional resources (e.g., hardware, clinical, human factors etc.) involved in Risk Management process activities.
• Act independently with minimal supervision. Expected to make suggestions on improvements based on recent technical knowledge.
• Manage risk-related Design History File (DHF) elements and associated documents, including the Risk Management File (RMF).
• Present and explain Risk Management File documentation and/or Baxter Product Risk Management procedures during external audits.
• Ensure consistent and robust product Risk Management processes are applied.
• Understand customers/market needs.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all data collection and reporting activities.
• Ensure good internal and cross-functional communication and regular status update of projects

Qualifications.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

• Knowledge of Renal Chronic therapies and Solutions products (HD, PD is a plus).
• Knowledge of product development stages, life cycle management and design control.
• Working knowledge of international/regional/national regulations and standards.
• Experience with tools related to structured risk control activities, for instance Failure Mode Effects and Analysis (FMEA), Fault Tree Analysis (FTA) with support from software’s like DOORS and Windchill Quality Solutions (WQS) and/or other Requirements Management & Risk tools as well as in Excel.
• Strong critical thinking and problem-solving skills.
• Familiarity with standards related to Risk Management: (e.g., ISO 13485, ISO 14971). Basic knowledge of standards covering Electromechanical devices (e.g., IEC 60812, IEC 61025, IEC 62366, IEC 60601, etc.) is a definite asset.
• Requires strong organization and good communication skills, with the ability to interface with both technical and non-technical personnel throughout the organization (interpersonal skills).
• Able to work with a cross-functional team in a fast-paced environment.
• Leadership and team player.
• Fluency in English, any other language is an asset.

Reasonable Accommodations

Baxter 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.

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