Development Quality Engineer II

About the Role

We are 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.

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

Requirements

• 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

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

Location: Plymouth, MN
Duration: 12 Month 100% On-Site

Benefits

• 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)