Development Quality Engineer II

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

Position Summary

Seeking a Quality Engineer with experience in medical device product development to support risk management, design controls, verification and validation, and regulatory compliance for electro-mechanical and software-enabled medical devices.

Title

Development Quality Engineer II

Location

Plymouth, MN

Duration

12 Month

100% On-Site

Position Summary

Seeking a Quality Engineer with experience in medical device product development to support risk management, design controls, verification and validation, and regulatory compliance for electro-mechanical and software-enabled medical devices.

Required Skills

• Strong verbal and written communication skills
• Excellent interpersonal and teamwork abilities
• Ability to work independently and manage multiple priorities
• Strong organizational and problem-solving skills
• Advanced computer proficiency
• Effective collaboration with cross-functional teams

Basic 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

Preferred Qualifications

• Advanced degree in Engineering or Technical Field
• Experience with electro-mechanical medical devices
• Knowledge of IEC 62304, IEC 60601-1, and IEC 60601-1-2 standards
• Experience with requirements management tools such as JAMA
• Experience with issue-tracking systems such as JIRA
• Working knowledge of statistics and its application to verification and validation activities

Key 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

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.