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Manager Design Assurance Engineering Resume Example

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Jessica Claire
, , 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Summary
Highly motivated Sales Associate with extensive customer service and sales experience. Outgoing sales professional with track record of driving increased sales, improving buying experience and elevating company profile with target market.
Experience
02/2020 to Current
Manager, Design Assurance Engineering Dynetics Fort Walton Beach, FL,

∙ 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.

08/2015 to 02/2020
Staff Design Assurance Engineer Abbott City, STATE,

∙ 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

01/2012 to 08/2015
Electronics Hardware Design Engineer Ingersoll Rand - Trane City, STATE,

∙ 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

02/2008 to 01/2012
Electronics Manufacuring Engineer Ingersoll Rand - Trane City, STATE,

∙ 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

Skills

Product Development Lifecycle

Medical Device Regulation

Root Cause Analysis

Education and Training
Expected in 12/2007
Bachelor of Science: Electrical Engineering
St. Cloud State University - St. Cloud, MN,
GPA:
Expected in 05/2015
MBA: Business Administration
Hamline University - St. Paul, MN,
GPA:

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Resume Overview

School Attended
  • St. Cloud State University
  • Hamline University
Job Titles Held:
  • Manager, Design Assurance Engineering
  • Staff Design Assurance Engineer
  • Electronics Hardware Design Engineer
  • Electronics Manufacuring Engineer
Degrees
  • Bachelor of Science
  • MBA

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