Medical Device Quality Engineer – Development & Validation

Abbott; Saint Paul (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (HSA)

Flexible Spending Accounts

Life Insurance

Short Term Disability

Long Term Disability

Critical Illness & Hospital Coverage

MetLife Benefits (ID Fraud, Pet)

Job summary

Abbott in Saint Paul, MN is seeking a Development Quality Engineer II to join its quality organization on a 12-month assignment. The role focuses on design control, process validation, risk management, and ensuring regulatory compliance throughout product development.

You will participate in or lead teams, develop and execute test plans, and contribute to quality systems supporting PDP and cPDP projects, with on-site work from 8AM to 4PM.

Qualifications

• Bachelor's degree in engineering or a technical field required.
• 2-5 years in R&D, process/manufacturing engineering, and/or quality with at least 1 year direct quality manufacturing support experience.
• Experience in medical devices and associated regulations/standards.
• Experience in process validation planning and execution.
• Experience in inspection method validation / test method validation.

Responsibilities

• Participate in or lead teams in supporting quality disciplines, decisions, and practices
• Lead on-time completions of design control deliverables
• Support on-time execution of Quality Plans for internal product development process (PDP), clinical product development process (cPDP), and design change projects
• Accountable for generation of process validation test plans/reports
• Accountable for generation of design verification test plans/reports for product/system requirements
• Lead or support Risk Management activities from concept through commercialization, including risk management plans/reports and hazard analysis, FMEAs, cybersecurity risk assessments
• Lead outputs and generate Essential Output reports
• Accountable for completion of labeling verification activities and reports
• Work with process engineering on manufacturing and process validation deliverables
• Collaborate with design engineering on customer/system/product requirements and product verification/validation
• Ensure DHF content completion, integrity, and regulatory/standards compliance
• Support device manufacturing activities from concept to commercialization
• Resolve gaps through collaborative communication
• Complete document change reviews timely
• Identify and implement effective process control systems
• Assist in CAPA systems and process controls implementation
• Assist in streamlining business systems to identify and resolve quality issues
• Apply systematic problem solving to quality issues
• Support QMS, EMS and regulatory requirements
• Maintain regular on-site attendance
• Additional duties as assigned

Skills

Verbal communication

Interpersonal

Teamwork

Independent contributor

Multitasking

Organization

Computer skills

Education

Bachelor's degree in engineering or technical field

Job description

Abbott in Saint Paul, MN is seeking a Development Quality Engineer II to join its quality organization on a 12-month assignment. The role focuses on design control, process validation, risk management, and ensuring regulatory compliance throughout product development.

You will participate in or lead teams, develop and execute test plans, and contribute to quality systems supporting PDP and cPDP projects, with on-site work from 8AM to 4PM.