Design & Development Quality Engineer II

Job Summary

Design and Development Quality Engineers drive project quality in all areas including all deliverables and ensure that development teams follow processes that are effective and compliant to SOPs. They work with both the customer and internal team members to drive successful outcomes and long-term value for both the customer and Forj Medical.

Job Duties And Responsibilities

• Participates/Approves in development of requirements, technical Reviews, test report development, design transfer coordination/support and FMEA, DFMEA development
• Participates in project/customer meetings and Leads Phase Reviews
• Monitors project activities to ensure following Forj Medical processes
• Collaborates with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified
• Uses cross functional knowledge to be able to support teammates in constraints arise
• Reviews/Approves regression analysis, Trace Matrix, ECOs, DBRs, DV Tool Qualifications, Test Procedures
• Manages and monitors Design and Development (DDF) file including creating development planning documents and verification reports
• Maintains Test Execution Management, Device Testing, Dry Run Status, Stage Build Process Compliance, and Safety/EMC Test Reports
• Drives Design Change assessments including planning and report documentation with cross functional support
• Affords assistance in the generation and/or execution of verification test procedures
• Ensures verification configurations tested are production equivalent by collaborating with other engineering disciplines and early stage to build knowledge
• Other duties as assigned

Qualifications

• Bachelor’s Degree/Technical Degree in Engineering or equivalent experience
• 3-5 years’ experience in a Medical Device manufacturing/product development environment
• Understanding of FDA QMSR, ISO 13485, IEC 60601, and IEC 62304 requirements
• Experience/knowledge with product/process verifications/validations
• Experience with DFMEAs, PFMEAs, Risk Management, Equipment Qualifications, and Statistical analysis

Preferred Qualifications

• Certified Quality Engineer (CQE) or equivalent experience
• Good project management skills and initiative in taking on and completing projects
• Good verbal and written communication skills
• Strong interpersonal, teamwork, and communication skills
• Strong written communication demonstrating the ability to simplify complex information

Employment Requirement

Must be authorized to work in the United States.

Compensation And Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.