Design Assurance Engineer II

Responsibilities

• Serve as a core team member for complex development projects and quality improvement initiatives.
• Execute holistic design and process verification and validation (V&V) strategies.
• Perform technical analysis of requirements, specifications, and control strategies.
• Support design and process characterization, including test and inspection method development.
• Lead root cause investigations and manage corrective and preventive action (CAPA) activities.
• Ensure the integrity and regulatory compliance of DHF, DMR, and DHR documentation.
• Participate in internal and external regulatory inspections (FDA, ISO).
• Apply statistical methods to design, process, and verification decisions.

Requirements

• Bachelor's degree in Engineering or a related technical field.
• 3+ years of engineering experience in new product development.
• 3+ years of quality engineering experience specifically supporting disposable ablation catheters.
• 3+ years of experience managing NCMRs, CAPAs, Stop Ships, and HHEs.
• Working knowledge of design/process verification and validation techniques.
• Proficiency in applied statistics, sampling strategies, and Minitab.
• Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971 standards.
• Ability to work onsite in Plymouth, MN, and travel approximately 10% (including international).

Preferred Qualifications

• Prior experience working within the medical device industry.

Benefits

• Career development opportunities within a global international company.
• Health Investment Plan (HIP) PPO medical coverage options.
• Excellent retirement savings plan with high employer contributions.
• Tuition reimbursement and specialized student debt/education programs.

About the Company

Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.