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Description

Provide technical leadership in Risk Management activities for medical devices. Drive standardized execution of Risk Management process that is effective, efficient, and compliant to Baxter processes and Regulatory Standards.

• Responsible for leading the activities associated with the Risk Management for products in various stages of the product lifecycle from new product development to post market surveillance.

• Drive completion of commercialization activities to achieve the launch of new products.

• Expedite, manage, and coordinate interrelated Risk Management 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 Risk Management.

• Facilitate an improved understanding of the interrelationship between Risk and Reliability.

• Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g. IEC 60812).

• Solid understanding and application of the standards related to Risk Management: (e.g., ISO 13485, ISO 14971, IEC 61025, IEC 62366, IEC 60601, etc.).

Major Responsibilities

• Provides leadership and subject matter expertise to product development teams to ensure Risk Management principles are applied throughout development cycle.

• Leads Risk Management activities in coordination cross functional teams globally.

• Collaborates with Engineering, Manufacturing, and external design partners in the development of design FMEA, Process FMEAs and roll-up into Risk Management files.

• Creates and approves Design History File deliverables associated with Risk Management.

• Provides ongoing risk analysis and identification of required risk mitigations to ensure safe, effective product.

• Recognizes strategy, evaluates risks, recommends actions and develops contingencies to address various scenarios.

• Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.

• Motivates and successfully influences stakeholders and cross-functional team members within the project.

Qualifications

• BS degree in Engineering, with approximately 5-8 years of practical Electromechanical Medical Device Design experience.

• Six Sigma Green belt or Black Belt (DFSS) certification a plus, LEAN certification a plus

• Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, verification and validation.

• Requires excellent interpersonal and communication skills.

• Prepare and present written and oral reports and other presentations to internal and external audiences as required.

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.
                                                                                                                                                               
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Pay Transparency Policy

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.