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.

MAIN PURPOSE OF THE ROLE

Responsible for completing Design Assurance activities in new product development from concept through commercialization. Conduct risk assessment/management and provide support to the regulatory department in
demonstrating compliance to QSR and ISO 13485 Quality System. Participate in cross-functional teams to implement design controls, validate test methods, plan verification and validation activities and provide critical quality review of protocol and report content. May support non-conformances, CAPA investigations, health hazard analysis, complaint investigations or supplier change notification activities for CSI products.

Essential Duties and Responsibilities:

• Partner with product development engineering, clinical, marketing, regulatory, and others to assure appropriate
quality requirements are defined for the specific device application and target patient population
• Lead cross functional teams in completing risk assessment and risk management activities
• Facilitate assessment and testing of biocompatibility for new and sustaining products
• Support regulatory submission content and review for compliance to QSR/MDD/MDR regulations
• Participate as member of a product development team responsible for supporting activities required to ensure
quality of the design through compliance with design controls
• Collaborate with R&D to create, optimize and validate mechanical and analytical test methods
• Support translation of user needs into design inputs and outputs.
• Work with cross functional team to plan and conduct design verification activities, human factors and design
validation activities
• Work with cross functional team to assess impact of proposed supplier changes
• Use statistical tools to analyze data and make acceptance decisions
• Provide support to Post Market Surveillance group to ensure trends are being assessed for impact to product risk
• Ensure technical accomplishments and other testing are fully documented for reference and traceability through
company systems

Qualifications:

• 4 Year / Bachelor or Masters of Science Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Industrial Engineering or related technical discipline.
• Minimum 5 years of experience in medical device or pharmaceutical industry or any other regulated industry.
• Regulatory compliance awareness in 21 CFR 820, ISO 14971, ISO 13485.
• Design assurance experience in risk management and design controls.
• Technical skills and ability to provide solutions to a variety of technical problems of moderate scope and
complexity.
• Practical approach to Quality and a partnering style with colleagues in all functions in the business.
• Technical writing and presentation skills.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.