Design & Development Quality Engineer II

Forj Medical•Saint Paul, MN

1d•$75,000 - $105,000•Onsite

About The Position

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.

Requirements

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
Must be authorized to work in the United States.

Nice To Haves

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.

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