Development Quality Engineer II

Title: Development Quality Engineer II

Location: Plymouth, MN

Duration: 6 Months

100% Onsite

Required Skills:

• Strong verbal and written communication
• Excellent interpersonal and teamwork skills
• Ability to work independently as an individual contributor
• Effective multitasking and time management
• Strong organizational and analytical skills
• Proficiency in advanced computer applications

Education & Experience

• Bachelor’s degree in engineering or a related technical field
• Relevant experience in quality, product development, or engineering domains preferred

Key Responsibilities

• Participate in and/or lead cross-functional teams to support quality processes, decisions, and best practices
• Ensure on-time completion of design control deliverables
• Support execution of Quality Plans for Product Development Process (PDP), Clinical Product Development (CPDP), and design change projects
• Develop and manage design verification test plans and reports for product/system requirements
• Lead or support Risk Management activities across the product lifecycle, including:
• Risk management plans and reports
• Hazard analysis
• FMECA (Failure Modes, Effects, and Criticality Analysis)
• Cybersecurity risk assessments
• Identify essential outputs and generate Essential Output reports
• Perform and document labeling verification activities
• Collaborate with design engineering teams to:
• Define customer/system/product requirements
• Complete product verification and validation activities
• Ensure Design History File (DHF) completeness, integrity, and compliance with regulatory standards
• Review document change requests objectively and within timelines
• Implement effective process control systems for product development and manufacturing
• Support CAPA (Corrective and Preventive Actions) and quality assurance systems
• Assist in developing and improving business systems to identify and resolve quality issues
• Apply structured problem-solving methodologies to address quality concerns
• Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance initiatives
• Perform additional duties as assigned based on project and business needs

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.