Development Quality Engineer II

Job Responsibilities

• Participate in or lead teams in supporting quality disciplines, decisions, and practices
• Lead on-time completions of design control deliverables
• Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects
• Accountable for generation of process validation test plans/reports
• Accountable for generation of PDP design verification test plans/reports for product/system requirements
• Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMEAs, and Cybersecurity risk assessments
• Accountable for completion of labeling verification activities and labeling verification reports
• Work with process engineering in the completion of manufacturing process deliverables such as manufacturing procedures and inspection procedures
• Work with process engineering in the completion of process validation deliverables such as inspection and test method development and equipment qualification
• Work with design engineering in the completion of customer/system/product requirements
• Work with design engineering in the completion of product verification and validation
• Ensure DHF content completion, integrity, and regulatory / standards compliance
• Support device manufacturing activities from product concept through commercialization
• Collaborative communication resolving gaps
• Complete document change request reviews in a timely and objective manner
• Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements
• Affirmative action plan compliant

Requirements

• Education: Bachelor level degree in an Engineering Discipline or other technical field
• Experience: 2-5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 1 year direct quality manufacturing support experience
• Experience: Experience in medical devices and associated regulations/standards
• Experience: Experience in process validation planning and execution
• Experience: Experience in inspection method validation or test method validation

Qualifications

• Preferred Qualifications: 2+ years in direct quality manufacturing support experience
• Preferred Qualifications: Experience in preparing risk assessments, FMEA, and other risk documents
• Preferred Qualifications: Experience with reflow and injection molding processes