Development Quality Engineer Resume Samples

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C Streich

Cullen

Streich

5390 Krajcik Lakes

New York

+1 (555) 631 8081

5390 Krajcik Lakes

New York

Phone

p +1 (555) 631 8081

Experience Experience

Phoenix, AZ

Development Quality Engineer

Phoenix, AZ

Fahey-Donnelly

Phoenix, AZ

Development Quality Engineer

Creates and ensures on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Drive systematic improvements in the development process internal as well as at subcontractors (supplier quality management)
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Drive Zero Defect product development across the development sites of the business unit
Support design test and inspection method development, and execute method validation activities
Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Working knowledge of Risk Management, ISO 14971, FTA and FMEA

Philadelphia, PA

Product Development Quality Engineer

Philadelphia, PA

Wyman, Hills and Pagac

Philadelphia, PA

Product Development Quality Engineer

Provide support in the development and content presentation to senior leadership in support the business as directed by the MRQ
Providing support in the development and content presentation to senior leadership in support the business as directed by the MRQ
Management (ordering, updating, issue disposition) of internal vehicle testing programs used to collect vehicle data
Establish partnerships both internally and externally and to influence without direct authority
Establishing partnerships both internally and externally and to influence without direct authority
Plan, prioritize, set goals, and manage multiple projects in a technical and business environment
Work closely with production unit leaders to stratify and eliminate Quality issues on the plant floor

present

Philadelphia, PA

Senior Development Quality Engineer

Philadelphia, PA

Gleason Inc

present

Philadelphia, PA

Senior Development Quality Engineer

present

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Develop and implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Provides technical assistance for diagnosing design and manufacturing quality problems
Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications

Education Education

Bachelor’s Degree in Engineering

University of California, Irvine

Bachelor’s Degree in Engineering

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15 Development Quality Engineer resume templates

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Product Development Quality Engineer Resume Examples & Samples

Resolution of warranty issues (via electronic corporate issue management system) associated with vehicle design, build, and testing
Development/assessment of 3rd Party targets (Consumer Reports, internal resources, JD Power)
Management (ordering, updating, issue disposition) of internal vehicle testing programs used to collect vehicle data
Providing support in the development and content presentation to senior leadership in support the business as directed by the MRQ
Working closely with production unit leaders to stratify and eliminate Quality issues on the plant floor
Engineering Quality point of contact on the RAM platform
Ensuring delivery of third party metric targets
Planning, prioritizing, setting goals, and managing multiple projects in a technical and business environment
Displaying effective communication skills to support meetings at all levels of the company, including senior leadership
Establishing partnerships both internally and externally and to influence without direct authority
Representing the "Voice of the Customer" to the platform teams
Driving team success by clarifying expectations and minimizing political hurdles
Demonstrating unwavering commitment to delivering results and champion achievements
Exhibiting a willingness to do things differently and consistently translate ideas into actions that deliver results
Possessing strong interpersonal skills with ability to work in a team environment
Bachelor's degree or higher in Engineering
Minimum 5 years' automotive related, design, development, quality experience
Strong Root Cause Analysis skills
Bachelor's degree or higher in Mechanical or Electrical Engineering
Previous experience with new vehicle launches
Assembly Plant Experience
Working knowledge of quality information systems

Development Quality Engineer Resume Examples & Samples

Responsible for the design and process generic validation plans / Innovation on all variants
Support definition and analysis of specification/ requirement data
Confirm the application of the product/ process standards
Participate in the lessons learned process
Ensure that the proper methodology and tools (testing fixtures and gauges) are used to verify the parts
Responsible to verify and analyze product conformity
Define the quality target and approve feasibility
Responsible to create prototype and pre-series control plans
Verify that the more stringent conditions are integrated for the tests
Ensure the Innovation/ Generic Process System key deliverables deployment
Support the SDF approach on product and process deployment lead by R&D and ME (Functionnal Analysis and FMEAs)
Participate to the prototypes reviews lead by prototype shop
Participate in the analysis of the simulations lead by simulation
Participate to the KPC/ KCC identification
Responsible of capabilities studies on KCC and KPC
Participate to the products/ process sensitivity studies
Results oriented with strong written and oral communications skills

Development Quality Engineer Resume Examples & Samples

Responsible for the proper prediction of, and the ultimate product performance of the mechanical system
Evaluates mechanical and electromechanical product design and ability to identify potential design issues and drive technical decisions
Drives design quality, reliability, and compliance to standards and regulations
Assists on-time completion of Design Control Deliverables
Creates and ensures on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Is accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations
Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization
Supports design test and inspection method development
Ensures DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Supports manufacturing process development & qualification for new product commercialization and product changes
Supports and ensures objective component specification definitions, supplied component, sampling plan development, and vendor qualifications
Supports and ensures internal & external audit responses
Bachelor level degree in Mechanical Engineering (or Closely related); Shall be proficient at predicting product performance with FEA
Experience in using a variety of engineering tools like Creo or other CAD experience
Working knowledge of Risk Management, ISO 14971, FTA and FMEA
Good statistical data analysis skills
Design for Six Sigma and Critical to Quality training and experience
2-5 years relevant experience within medical device preferred
Experience designing and testing medical devices preferred

Principal Development Quality Engineer Resume Examples & Samples

Lends expertise in navigating multiple quality systems to accomplish product development
Facilitates on-time completion of design control deliverables per appropriate processes
Creates and ensures on-time execution of Quality Plans for development programs
Lends technical expertise to product design and design requirements
Is accountable for design verification and validation test design, planning, execution, and compliance
Ensures DHF content completion, integrity, and regulatory & standards compliance
Supports manufacturing process development in collaboration with operations quality engineers
Supports and ensures the establishment of proper customer and product requirements
Supports and ensures objective component specification definitions, sampling plan development, and vendor qualifications in collaboration with supplier quality engineers
Communicates with a broader team of development quality engineers at multiple sites to coordinate system-level activities that are owned by the Quality department
Works directly with the onsite development team and program management to evaluate progress and adjust accordingly
Upon completion of major programs, continues to perform other development quality activities as determined by supervisor and supports development programs in Sylmar, CA and Sunnyvale, CA
Bachelor-level degree in technical field, preferably Biomedical, Electrical or Mechanical, with electronics experience
5+ years’ experience in a technical role
Experience with quality management systems, preferably ISO 13485 and 21 CFR 820
Working knowledge of Risk Management, preferably ISO 14971
Demonstrated communication and interpersonal skills, with ability to work autonomously and in teams
Ability to solve quality-related issues in a timely manner
Experience working in a broader enterprise/cross-division business unit model
Advanced degree in technical or management fields
Previous quality engineering experience and demonstrated use of quality tools/methodologies
Previous medical device experience
Prior product design/development experience
Statistical data analysis skills
ASQ CQE certification

Senior Software Development Quality Engineer Resume Examples & Samples

Do you bleed software quality?
Are you passionate about building software that is used by Executives to manage their business?
Do you value and like working with a very tight knit team?
Independently designs and delivers code for products with a quality mindset
Provides oversight through code and design reviews for features delivered by other developers within their scrum team
Interface with customers to understand real life usage, build test cases
Organize and drive cross product testing
Advocate for customer enhancements
Works closely with senior developers, PM, and UX to ensure their features are delivered to meet business and quality requirements
You are providing leadership and coaching to others on your scrum teams, as well as providing mentoring to others who may be on other scrum teams

Mopar Product Development Quality Engineer Resume Examples & Samples

Keep up-to-date on latest specification and standards from bestandard
Support DFMEA and DVP development for new or high risk commodities
Support review of Design Best Practice Documents, which include DVP
Modify existing DVPs to the latest specifications and standards working with engineering
Work with engineering to update lessons learned into the Design Best Practice Documents
Support other international regions EMEA, APAC and LATAM accessory teams with DVP development and engineering specifications, as needed
Support system and vehicle level testing by coordinating tests and reporting on results
Analyze monthly accessory part warranty data and identify issues
Resolve identified issues through Root Cause Analysis, validation and implementation of the fix with engineering
Feed forward lessons learned to engineering Design Best Practice Documents
Must have practical experience in Engineering, Product Development Quality or Manufacturing Quality within an automotive organization with understanding of quality procedures and system requirements
DFMEA and DVP development process
Review of drawings
Automotive specifications and standards
Regulatory and safety requirements
Reliability Engineering
Warranty data analysis
Review parts returned from dealerships/field
Product development and release experience
Teamwork and interpersonal skills with cross functional team
Excellent critical thinking analytic and problem solving skills
MS Office proficiency, including presentation and MS Excel
Must be self-motivated, results driven, able to work with minimal supervision
WDSS, WIS, QNA, CLIMS PRAS systems skill
Understanding of bestandard processes
Understanding of Mopar Accessory Warranty Data process

Development Quality Engineer Resume Examples & Samples

Monitor and support process compliance of development teams
Drive Zero Defect product development across the development sites of the business unit
Analyze the product quality of development projects on an ongoing basis, determine gaps in way of working, organizational processes and suggest improvement proposals
Maintain & deploy guidelines for automotive quality IC and SW that meet the needs of the business and customers
Auditing IC and SW projects and subcontractors as well as creation processes and quality systems
Drive systematic improvements in the development process internal as well as at subcontractors (supplier quality management)
Prepare project gates from the development quality perspective
Participate and represent quality in the Business Line gate reviews and report identified, not properly mitigated risks to the Quality Manager
Customer interaction: Present the SW and IC quality assurance process to customers, contribute to quality agreements, prepare SW teams for assessments

Software Development Quality Engineer Resume Examples & Samples

Execute and support on-time completion of Design Control Deliverables
Represent Quality Assurance on cross-functional development teams to provide guidance and support for design controls, risk management, and regulatory strategy
Support Risk Management activities from product Concept through Commercialization
Design and perform acceptance testing on software systems
Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support the ongoing maintenance of the quality system (internal and external audits, CAPA, NCMR, complaints) and lead proactive quality system improvements
Contribute to product design reviews, risk analyses, and document reviews
Automate processes and software/systems testing
Bachelor level degree in Computer Science or equivalent practical experience
3-5 years’ experience in medical device development and/or other highly regulated industry
Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
Experience with software development, using languages such as C, C++, C#, or Java
Experience with systems engineering, system requirements management, and system level risk management strategies
Meticulous and methodical with high attention to detail
Ability to maintain regular and predictable attendance
Advanced degree (e.g. MS) or equivalent practical experience
Strong foundation in computer science, with strong competencies in data structures, algorithms, and software design
Capable of deep-dives into code
Strong verbal and written communications with ability to effectively strategize and communicate at multiple levels in the organization
Strong organizational and follow-up skills

Senior Development Quality Engineer Resume Examples & Samples

Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures
Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes
Provides guidance for the design and development of company products
Four year degree in a technical field, preferably mechanical, chemical, biomedical, industrial, materials science, biochemistry, chemistry, physics or management required
Advanced Degree in Computer Sciences, Systems Engineering, or Embedded Systems preferred
3+ years’ software testing, development and or validation experience, including lead or supervisory experience
Detailed knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
Experience with systems engineering, system requirements management, and system level Risk Management strategies
Experience with software reliability
Ability to travel approximately 15%, including internationally
5-7 years of experience in medical device development and/or other highly regulated industry
Masters in Computer Science or Systems Engineering
Experience with Class III medical devices
Programming experience with test automation scripts

Software Development Quality Engineer Resume Examples & Samples

Generate quality plans for product development process (PDP)
Generate plans and reports, outlining the risk management strategy for PDP and regulatory submissions
Lead in the completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments
Generate design verification test plans and reports for product and system requirements
Perform labeling verification and generate labeling verification reports
Work with design engineering in the completion of software/system requirements
Work with design engineering in the completion of product verification and validation
Participate in PDP teams in supporting quality disciplines, decisions, and practices
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
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
Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
BS degree in Computer Science, Computer/Electrical Engineering or equivalent experience
0-2 years’ experience of Software Quality Engineering experience
Experience with iOS and mobile apps development is a definite plus
Experience with formal software development methodologies and source code management preferred
Experience with software configuration management preferred
Experience with defect management and issue tracking tools is preferred

Development Quality Engineer Resume Examples & Samples

Lead on-time completion 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 completion of labeling verification activities and labeling verification reports
Work with design engineering in the completion of customer/system/product requirements
Complete Document Change Request Reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives
Bachelor level degree in Engineering or other Technical Field
2-5 years’ experience
Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485
Experience supporting product design and development
Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
Ability to work in a highly matrixed and geographically diverse business environment

Principal Development Quality Engineer Resume Examples & Samples

Execute on-time completion of design control deliverables
10 years’ experience in R&D or Quality role
Bachelor level degree in an Engineering Discipline
Advanced (Masters) degree
Degree in Electrical, Mechanical, Software or Biomedical Engineering
5-10 years’ experience in R&D

Development Quality Engineer Resume Examples & Samples

Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Lead or support Risk Management activities from product Concept through Commercialization
Support design test and inspection method development, and lead method validation activities
Support internal & external audit responses
Support product re-certifications
Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Support execution of biocompatibility and sterilization qualifications
Bachelor level degree in Engineering or Technical Field
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Working understanding of FDA, GMP, and ISO 13485
Working understanding of the following standards 60601, 62304, &/or 14971

Development Quality Engineer Resume Examples & Samples

Product engineer, Quality engineer
Data base knowledge
Customer warranty portals (Covisint/AWS/SuplierPower/EWT/QNA/PRAS/WIS/GIM/SQIDS)

Experienced New Product Development Quality Engineer Resume Examples & Samples

Developing an in-depth understanding of user needs
Participating in the device design cycle on a fast-paced product development team
Translating user needs into design inputs and/or design specifications
Developing and validating test methods for the range of design verification activities required for endovascular devices
Performing and documenting design verification activities
Understanding product processing and manufacturing methods in order to transition new products into manufacturing
Selecting, evaluating, and validating components from various potential supply sources
Using the quality, complaints, design control, corrective and preventive action, risk management, and non-conforming product systems
Designing, executing, and analyzing experiments based on statistical techniques
Developing visual standards
Writing procedures and also training and assisting technical associates
Contributing to and/or managing various Design Control activities
Mentoring and driving best practices across multiple product teams
Bachelor's degree in science or engineering
Minimum of 5 years' experience as a product-development engineer
Experience in test method development and specification development
Demonstrated ability to prioritize, initiate, and drive projects to completion
Demonstrated excellent written and oral communication and presentation skills
Knowledge of Design Control activities and best practices
Solid knowledge of engineering fundamentals and ability to apply this knowledge to manufacturing and product design
Knowledge of the fundamentals of statistics
A work style of hands-on involvement with all phases of projects
Ability to network and interact effectively with a broad range of associates internally as well as external suppliers spanning various disciplines and responsibilities
Ability to work effectively in team situations as well as independently
Advanced technical degree

Senior Development Quality Engineer Resume Examples & Samples

Lead 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 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, FMECA’s and Cybersecurity risk assessments
Lead identification of essential outputs and generate Essential Output reports
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Technical review of DV protocols, reports and test method validations
SW/FW configuration management & maintenance, including system and subsystem level regression test coverage analysis, ATE support and NPS support
5+ years’ experience
Detailed knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485

Product Development Quality Engineer Resume Examples & Samples

Provide project direction, coaching, mentoring and supervision for quality engineering and technical team personnel
Lead and implement complex projects including quality improvement initiatives
Working knowledge of basic and advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.)
Demonstrate strong project management skills and lead cross-functional teams
Working knowledge of risk assessment tools (e.g., ISO 14971, FMEA’s, FTA)
In-depth knowledge of quality engineering principles and methodologies
Working knowledge of process validation strategies (inclusive of I/O/P), software validation, design controls, CAPA, NC, etc
Provide leadership in understanding of the regulations to other disciplines
Support and lead product Design Control activities for new product development efforts
Conduct and lead Process/Design Validation activities and approach
Conduct Process/Design Failure Mode Effects and Analysis
Support Manufacturing Engineering in the creation of travelers, routes, bills of material, print changes, and specifications for in-house manufacturing
Conduct Internal Audits of the Quality System
Conduct audits of new suppliers as part of the project teams
Communicate effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Sales, Supply Chain and Marketing in order to provide quality input
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
Strong quality engineering skills with a proven track record in design verification/validation and failure mode effects and analysis is also required
A minimum BS degree in a technical discipline with 5 years of related experience for Quality Engineer
5-10 years of direct and/or related quality work experience in a regulated environment
Knowledge of the QSR and ISO9001/EN46001 quality requirements
Interpersonal skills that foster conflict resolution as it relates to technical situations
This position will be based out of Palm Beach Gardens, FL and require up to 10% travel.7157170405

Development Quality Engineer Resume Examples & Samples

Design verification and validation test planning
Design verification and validation test protocols and reports
Design input output trace matrix
DHF organization
Requirement review
Regulatory responses and submissions
Risk/hazard analysis and risk management plan/reports
Design specification reviews
Quality plans
Design change plan/reports
Internal and external audit findings and responses
Corrective and preventive action resolution
Change requests
Ability to work independently with minimal/no supervision
Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
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
Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance

Product Development Quality Engineer Resume Examples & Samples

Actively participate on project teams
Participate in drawing reviews both internally and with Suppliers
Work with Product Development and Testing groups to assist in developing product and component test plans and reliability assessments against warranty requirements
Participate in DFMEA process
Work with Purchasing, Engineering and Supplier Quality to help coordinate Early Supplier Involvement (ESI) activities
Participate in Engineering Builds
Attend Plant Pilots and work with Plant Quality to ensure Manufacturing Quality Plan is completed
Lead PFMEA and Control Plan development
Review Gage R&R and Cpk information
Interface with Compliance and Regulatory Groups to ensure all requirements are clearly defined and any verification or testing requirements are met
Provide guidance and training in MTD’s PPAP requirements
Review and disposition PPAP’s for certain designated parts and/or assemblies
Participate in Risk Assessments relative to Product Development projects
Track Critical to Quality Metrics relative to Product Development Projects
Drive Cost of Quality into products, and deliver to desired customer expectations and star ratings
Support customer returns, failure analysis, and corrective actions
Travel up to 15% of time – International travel required
Bachelor’s Degree or one to two year related experience or equivalent education and experience

Development Quality Engineer Senior Resume Examples & Samples

Manages PPAP readiness, define PPAP requires and PPAP binder
Defines validation concpet and coodinates efforts with AQL and customer approval
Active support of PM in all quality and safety relevant aspects during quotation, development and launch process
Participates and moderates Gate reviews
Monitor if the internal and external requirements are met
Evaluate application of Qrelated requirements and decide the release of the product / system
Drive the analysis of product and process weaknesses, initiate and/or apply measures for quality improvements
5 years of experience in the automotive, customer or indusctrial electronics industry

Software Development Quality Engineer Resume Examples & Samples

Work with Project Managers and Development managers to oversee software life cycle
Work to understand the business/industry and unique needs of our clients and end users
Overall accountability for quality software including the functionality, usability and performance of our products
Solving complicated problems with multiple systems involved
Technical knowledge and experience to maximize opportunities and constraints of different platforms/code bases
Mobile, Web and Desktop testing experience
Experience working in an agile development environment. Ability to work design process into agile methodology
Use bug tracking system effectively to maximize product quality and productivity for Development personnel
Technical documentation for regulatory requirements
Bachelor’s degree in Engineering or related discipline with at least 2 years of QA experience
Experienced reading and understanding popular web programming languages, e.g. C#, SQL and HTML
Strong analytical, planning, and organizational skills with an ability to manage competing demands

Senior Development Quality Engineer Resume Examples & Samples

Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Lead Risk Management activities from product Concept through Commercialization
Support manufacturing process development & qualification for new product commercialization and product changes
Support and ensure internal & external audit responses
Support and ensure on-time product re-certifications
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner Develop and lead other team members
5-8+ years experience
Advance degree

Development Quality Engineer Resume Examples & Samples

Responsible for the proper prediction of, and the ultimate product performance of the electrical system
Evaluates product design to identify potential design issues and drive technical decisions
Able to troubleshoot and debug electrical design issues and drive technical decisions
Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Support design test and inspection method development, and execute method validation activities
Supports DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Bachelor level degree in Electrical or Electronics Engineering, or equivalent; advanced degree preferred
2-5 years’ experience in with electrical design, systems, or quality
Solid fundamental understanding of analog and digital circuits
Hands on experience with lab testing and debugging of electrical circuits using standard lab equipment
Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills with ability to effectively communicate at multiple levels in the organization
Advanced personal computing skills, including report writing, and familiarity with common MS Office applications
Experience in electrical circuit design and testing
Experience in using a variety of electrical engineering tools for design simulation and/or modeling
Experience/knowledge with EMI/EMC, Wireless Coexistence, and/or MR environment exposure on active implantable medical devices (simulation and testing)
Familiarity with FDA/ ISO and IEC standards and regulations

Automated Test Development Quality Engineer Resume Examples & Samples

Plans, performs and documents development quality related activities, including but not limited to quality test, procedures for new and modified products and components, engineering test, and reliability tests
Collaborates with R&D and Project Managers to establish test design and acceptance criteria. acceptance criteria
Designs and conducts Process Validation Plans related to products being qualified and new equipment. Writes clear, concise, and complete reports
Uses laboratory test equipment and instrumentation to obtain test data from the devices and be capable of anaylzing the data
Audits software verification. Verifies test equipment/software repeatability
Support quality activities ensuring automated test verification and validation planning, execution, and deliverables comply with quality system regulations
Responsible for running compliance and/or performance tests as needed to ensure delivery of a test system, and conducting cross-functional root-cause analysis investigation and issue resolution activities
Support and ensure the establishment of objective, measurable, discrete, and verifiable test design requirements
BS degree in Engineering (e.g., Electrical, Computer science, etc.), or in a physical science, a related field, or equivalent
Typically a minimum of three plus years of progressively more responsible work experience in a high technology manufacturing environment
Broad cross-disciplinary and in-depth knowledge of the development quality profession
Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees
Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks
Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications
Documented record of delivering design assurance engineering information which adds value to management's decision making process

Product Development Quality Engineer Resume Examples & Samples

Bachelor's degree in Engineering (Electrical, Mechanical, Aerospace/Aeronautical, Biomedical/Biomechanical/Bioengineering, Chemical, Civil, Materials)
2 years' automotive related design, development, quality experience
5 years of automotive related design, development, quality experience
Experience with new vehicle launches

Product Development Quality Engineer Resume Examples & Samples

Provide support in the development and content presentation to senior leadership in support the business as directed by the MRQ
Work closely with production unit leaders to stratify and eliminate Quality issues on the plant floor
Ensure delivery of third party metric targets
Plan, prioritize, set goals, and manage multiple projects in a technical and business environment
Establish partnerships both internally and externally and to influence without direct authority
Deliver a premier product to the consumer through commitment and dedication
Willingness to do things differently and consistently translate ideas into actions that deliver results
2 years of automotive related, design, development, quality experience