Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

REQUIRED QUALIFICATIONS

• Bachelors Degree with a minimum 5+ years of progressive work experience in medical device.
• Proven ability to manage and coordinate multiple concurrent projects across diverse international locations, ensuring alignment with regional regulations, cultural nuances, time zones, and stakeholder expectations while maintaining consistent quality, timelines, and budget adherence.
• 25% domestic and (some international) travel will be required for this role.

PREFERRED QUALIFICATIONS

Regulatory Knowledge:

• Understanding and complying with regulatory requirements (e.g., FDA, ISO 13485) is critical to ensure that the products meet all necessary standards and can be marketed legally.

Technical Expertise:

• A deep understanding of the technical aspects of medical device design, manufacturing processes, and validation methods is necessary to overseethe development and transfer processes effectively.
• Typically the Subject Matter Expert on one or more Quality System Subsystems.

Quality Control and Risk Management:

• Implementing robust quality control measures and risk management strategies to ensure product safety and efficacy throughout the design transfer and manufacturing processes.

Change Management:

• Managing changes in design, processes, and regulations efficiently to minimize disruptions and ensure continuous improvement.
• Demonstrated experience in working effectively to ensure quality and compliancerequirements are designed/built into the products.
• Demonstrated understanding of product development lifecycles, design change and change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing.
• Strong leadership skills, including the ability to set goals and provide positive andconstructive feedback respectfully to build positive relationships and improve business results.

Strong Project Management Skills:

• Effective planning, scheduling, and resource allocation are essential to manage the complexities of design transfer & new product introductions.

Cross-Functional Collaboration:

• Working closely with R&D, quality assurance, regulatory affairs, and manufacturing teams ensures that all aspects of the product development lifecycle are aligned and any potential issues are addressed early.

Effective Communication:

• Clear and consistent communication with all stakeholders, including team members, suppliers, and regulatory bodies, is vital to ensure that everyone is on the same page and any issues are promptly addressed.

Please refer the Job description for details