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. Design and Development Quality Engineer II will work under the direction/supervision of more senior Design QA staff members to ensure resolution of technical issues and knowledge transfer. They assist in the development of verification and validation activities on medical devices and medical device systems. Verification testing may involve GUI testing, black-box system testing, environmental testing, requirements based functional testing and low-level hardware testing and fault simulation.

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. 
• Collaborated 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. 
• Monitors 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.
• Assists 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

Required 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
• Must possess good project management skills and initiative in taking on and completing projects 
• Must possess good verbal and written communication skills 
• Must be able to manage and prioritize multiple projects/objectives 
• Strong interpersonal, teamwork, and communication skills.   
• Strong written communication demonstrating the ability to simplify complex information. 

Working Conditions:

• Office environment
• Manufacturing environment