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 statement: We are an equal opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, veteran status, or any other protected characteristic.

Requirements

• 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: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience
• Experience: 2+ years in direct quality manufacturing support experience