Medical Device Quality Engineer II — Risk & Design Controls

Abbott; Minneapolis (MN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (for High-Deduc

Flexible Spending Accounts (Health, LP

Supplemental Life Insurance

Short Term Disability (coverage varies

Long Term Disability

Critical Illness, Hospital coverage, 0

MetLife Legal, MetLife ID Fraud, and M

401(k)

Job summary

Abbott seeks a Development Quality Engineer II to join its medical device quality team in Plymouth, MN. This role focuses on risk management, design controls, verification and validation, and regulatory compliance for electro-mechanical and software-enabled devices.

You will collaborate with R&D and manufacturing to ensure robust quality systems and product reliability. Responsibilities include leading risk activities across the lifecycle, maintaining FMEAs, and supporting PDP/CPDP projects.

Qualifications

• Bachelor's degree in Engineering or a Technical Field
• Minimum 2 years of experience supporting medical device product development
• Experience in R&D, Quality Engineering, Process Engineering, or Manufacturing Engineering
• Knowledge of medical device regulations and applicable standards
• Experience in test method development and validation
• Experience preparing and maintaining risk management documentation, including Hazard Analysis and FMEAs

Responsibilities

• Lead and support Risk Management activities throughout the product lifecycle, from concept through commercialization
• Develop and maintain Risk Management Plans, Risk Management Reports, Hazard Analyses, Design FMEAs, and Software FMEAs
• Lead identification of Essential Outputs and generate Essential Output Reports
• Ensure compliance with design control requirements and timely completion of quality deliverables
• Support software verification and compliance activities in accordance with applicable standards, including IEC 62304
• Develop and execute design verification test plans and reports for product and system requirements
• Partner with Design Engineering teams to define, document, verify, and validate customer, system, and product requirements
• Support Product Development Process (PDP), Clinical Product Development (CPDP), OEM development projects, and design change activities
• Support product qualification and ongoing manufacturing activities to ensure compliance with internal and external requirements
• Participate in cross-functional teams to drive quality decisions and risk-based problem solving
• Support Quality Management System (QMS), Environmental Management System (EMS), and regulatory compliance initiatives
• Perform additional responsibilities as assigned to support business and project objectives

Skills

Strong verbal and writtencommunication

Interpersonal and teamwork

Independent work and time management

Organizational and problem-solving

Advanced computer proficiency

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Technical Field

Advanced degree in Engineering or Technical Field

Tools

JAMA

JIRA

Job description

Abbott seeks a Development Quality Engineer II to join its medical device quality team in Plymouth, MN. This role focuses on risk management, design controls, verification and validation, and regulatory compliance for electro-mechanical and software-enabled devices.

You will collaborate with R&D and manufacturing to ensure robust quality systems and product reliability. Responsibilities include leading risk activities across the lifecycle, maintaining FMEAs, and supporting PDP/CPDP projects.