JOB DESCRIPTION:The Opportunity: Lead and oversee all Design Assurance and Design Control activities for implantable medical devices, ensuring compliance with applicable regulatory requirements, industry standards, and quality system regulations throughout the product lifecycle. Partner closely with R&D and cross-functional teams to integrate quality into the design process, maintain robust design controls, and deliver safe, effective, and high-quality products that meet user needs, intended use requirements, and customer expectations.
What You'll Work on: - Lead and oversee the Design Assurance organization across software, electrical, mechanical, systems, and clinical quality functions.
- Establish and maintain compliant design control processes throughout the product lifecycle, from concept through commercialization and post-market support.
- Partner with R&D, Regulatory Affairs, Clinical, Manufacturing, and other cross-functional teams to ensure quality is integrated into product development.
- Ensure compliance with global medical device regulations, standards, and company quality system requirements.
- Provide quality leadership for design planning, design reviews, risk management, verification, validation, design transfer, and design changes.
- Drive risk-based decision making to ensure patient safety, product reliability, and regulatory compliance.
- Ensure products meet user needs, intended use requirements, and performance expectations through effective quality oversight.
- Serve as the quality authority for product development phase gates, design decisions, and major design changes.
- Lead regulatory inspection and audit readiness activities related to design controls and product development.
- Develop, mentor, and grow a high-performing Design Assurance team while driving continuous improvement of quality processes and organizational capabilities.
Required Qualifications: - Bachelor's Degree, Life Science, Engineering or related disciplines
- Minimum 10 plus years of experience in multiple business disciplines (such as quality, regulatory, manufacturing engineering, operations) with companies engaged in the manufacture of FDA regulated products.
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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $218,700.00 - $437,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:CRM Cardiac Rhythm Management
LOCATION:United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)
