∙ Oversee completion of design and development deliverables for new product development and sustaining engineering projects on EP Capital Equipment products including complex electrical-mechanical systems.
∙ Establish direction and objectives for the Design Assurance Engineering department overseeing department of 15+ engineers.
∙ Lead employees in driving continuous improvement in department processes
∙ Responsible to hire, train and develop engineering staff.
∙ Provide routine communications with cross functional management staff to ensure alignment in activities and procedures
∙ Assess and develop employee performance and skillset to assure effective support.
∙ Establish and maintain Quality Systems that are in compliance with regulatory requirements and meet business needs.
∙ Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
∙ Assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
∙ Lead on-time completion of Design Control Deliverables
∙ Create and ensure on-time execution of Quality Plans for internal development (PDP), OEM-based, and design change projects
∙ Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
∙ Lead Risk Management activities from product Concept through Commercialization
∙ Support design test and inspection method development, and lead method validation activities
∙ Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
∙ Support and ensure internal & external audit responses and on-time product re-certifications
∙ Detailed knowledge of FDA, GMP, and ISO 13485 and of IEC 60601, 62304 and 62366
∙ Provide supervision and coaching to direct report staff of junior engineers
∙ Improve quality and reliability of controls products
∙ Identify and implement resolution within CAPA system
∙ Perform failure analysis of field warranty returns and compile root cause summary
∙ Data analysis for controls quality metrics including monthly reporting to leadership
∙ Perform circuit analysis and PCB/PCBA layout activities related to product design improvement including design review, DFMEA, and CTQ activities
∙ Continuation support including manufacturing and obsolescence issues
∙ Identify and complete appropriate qualification/agency testing activities
∙ Lead schedules and gate reviews for assigned projects
∙ Building Controls Representative for company's Reliability Committee
∙ Provide daily support and maintenance to test systems in production environment for PCB assembly process.
∙ Develop work instructions and procedures for assembly and testing of products using lean manufacturing practices
∙ Develop and implement in-circuit test (ICT) fixtures for new products
∙ Manage internal quality system and monitor/report first-pass yield to leadership
∙ Lead and coordinate yield improvement projects to eliminate/reduce defects during PCB component surface mount (SMT), AOI and assembly process.
∙ Provide capacity measurements and plant utilization analysis
∙ Manage, develop schedule, and coordinate execution of all operations prototype projects
∙ Internal ISO 9001 Auditor
Product Development Lifecycle
Medical Device Regulation
Root Cause Analysis
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