Engineer II, Design Transfer

Responsibilities

• Contribute to the seamless design transfer of medical products from conception through manufacturing validation and compliance.
• Establish standard methods for manufacturing testing and document requirements for Production Safety Test Systems (TSR).
• Create, review, and manage manufacturing test specifications and disposition documents.
• Manage requirements and decomposition of system-level requirements using tools like DOORS or POLARION.
• Execute risk management processes in accordance with EN ISO 14971 throughout the product life cycle.
• Lead compliance efforts for IEC 60601-1 and collateral standards to meet notified body requirements (e.g., UL, TUV, ETL).
• Collaborate with contract manufacturers and internal manufacturing sites to sustain validated status for products and testing.
• Provide technical guidance to other engineers regarding design reviews and complex problem resolution.

Requirements

• Bachelor's Degree in Mechanical, Electrical, Electronics, Software, Biomedical, Industrial Engineering, or a related field.
• 3 to 8 years of experience in Electro-Mechanical System Design, specifically within manufacturing and testing functions.
• Proven experience in Medical Device development and familiarity with FDA Regulations and MDR.
• Strong understanding of FDA, ISO, and IEC design control procedures and standards.
• Knowledge of IEC 60601-1 (medical device safety) and IEC 62304 (software life cycle processes).
• Proficiency with requirements management tools such as DOORS or POLARION.
• Experience with engineering methodologies including QFD, Pugh Matrix, CTQ, DFR, and DFX.

About the Company

Baxter is a global healthcare leader dedicated to saving and sustaining lives. Our Front Line Care business unit provides essential products for airway clearance, cardiology, and patient monitoring to help manage chronic and acute respiratory and cardiac diseases. We foster a culture of courage, trust, and collaboration to redefine healthcare delivery.