SUMMARY:

• Possesses a unique perspective by working in regulated and non - regulated industries; as well as a myriad of engineering roles
• Focuses on reliability and life-cycle aspects in product design and development
• Recognizes the value of measurement tracking and recording
• Drives product compliance to military, laboratory and medical device standards
• Accomplished in designing, redesigning and implementing complex hardware and software systems
• Interacts with and supports company stakeholders and vendors at a high-level
• Provides forward-looking strategies in Project and Resource Management
• Evaluates product performance, and redesigns systems, to overcome deficiencies
• Simulates and prototypes electrical systems to avoid performance, Safety and Confidential issues
• Possesses a high level of skill in structured programming including C, LabVIEW and Visual Basic
• Experienced with OrCAD and Altium schematic capture, board layout, and simulation design tools
• Supremely proficient in the usage of MSOffice products
• Continuation and Sustaining Engineering
• Electrical Design/Development Engineering
• Compliance Engineering
• Approvals Engineering
• Product Engineering
• Test Engineering
• Manufacturing Engineering
• Quality Engineering
• Risk Management
• Project Management
• Resource Management

PROFESSIONAL EXPERIENCE:

Confidential - Danvers, MA

Senior Sustaining Electrical Engineer

Responsibilities:

• Perform Root Cause Corrective Action activities on Automated Controller consoles

Confidential - Houston, TX

Design Assurance Quality Engineer

Responsibilities:

• Interface with Program Managers and teams to convey project’s statuses
• Strategize and Manage complex compliance scenario on Safety, Confidential and RTA testing of system consisting of implantable and external components
• Modified several product design requirements to align with standards’ needs
• Utilize ANSI/AAMI PC69; EN 45502; ISO 14708; ISO 14117; 60950; 60601, 3rd-edition; and FCC/IC/EN Transmitter testing standards to navigate product compliance
• Support test labs to meet product compliance and acquire product
• Compose numerous verification protocols and reports to guide and document testing
• Manage in-house compliance testing by personnel and overseeing testing

Confidential - Portage, MI

Approvals Engineer

Responsibilities:

• Support new product development by scheduling, managing and executing Confidential testing at Stryker Instruments, Confidential and Confidential
• Interact with UL to achieve successful UL file transfer, IPI (initial product inspection) and documentation audits
• Perform Approvals activities to guarantee 60601-1, 2nd Edition compliance on Gaymar products
• Confirm legacy product designs are manufacturable by performing complaint investigations, DHF reviews, procedure assessments and MDR reviews
• Execute 60601-1 testing on legacy products, to assess compliance to 60601-1, 2nd Edition
• Evaluate revision history using JDE and AS400 ERP systems

Confidential - Ann Arbor, MI

Senior Electrical Engineer / Systems Engineer / Project Manager

Responsibilities:

• Reviewed Design History File and identified several document deficiencies
• Updated design history documents to ensure they accurately reflect claimed and realized performance
• Technical reviewer and engineering consultant on V&V protocol documents, to maximize document accuracy
• Mined Design History File (DHF) data from Matrix archive system, to guarantee new document development accuracy
• Directed activities to ensure specifications and protocols correctly supported 60601-1 family of standards
• Designed and prototyped electrical system used for verification testing
• Validated test fixtures to prepare for usage at vendor site, and ensure performance
• Tracked project using Rational DOORS (FKA - Telelogic DOORS) and Microsoft Project, to maintain traceability and control

Confidential - Eden Prairie, MN

Senior Electrical Engineer / Project Manager

Responsibilities:

• Sole electrical engineer who performed all EE functions including: design, prototyping, project management, resource-management and vendor-liaison activities.
• Performed DHF Gap Analysis on legacy system, to establish compliance with 60601-1 3rd edition
• Created Trace Matrix and Risk Priority Numbering scheme to document performance expectations
• Applied ISO 14971 to assess and establish risk requirements
• Managed design activities, to assure project schedule was maintained
• Administered resource-management activities, to guarantee product repair schedules were maintained
• Designed and prototyped Microchip PIC 18F and Freescale K60 microcontroller-based electrical systems to be used on next-generation product
• Analyzed and adapted legacy V&V protocol and DHF risk documentation for next-gen product

Confidential - St. Louis Park, MN

Senior Electrical Design Engineer

Responsibilities:

• Designed and implemented electrical systems on product to shorten time-to-market
• Improved programming structure of firmware for NXP LPC2368 microcontroller to ensure product performance
• Executed V&V on system to ensure circuit and software functionality
• Controlled document revisions using Telelogic DOORs to improve traceability
• Performed circuit analysis and debug of micro-controller circuits resulting in improved performance
• Coordinated, managed and performed UL 979, EN 61010 and EN 61326 compliance testing at NRTL to ensure performance targets were met

Confidential - St. Paul, MN

Senior Electrical Design Engineer

Responsibilities:

• Monitor Contract Manufacturer performance via site visits and performance metric tracking
• Created test protocols to perform reliability testing, and organized the archiving of results
• Developed and validated traffic-management product using LabVIEW-controlled tester, shortening its time-to-market
• Utilized Altium Designer to facilitate schematic capture and PCB layout electrical design activities, to ensure successful V&V compliance
• Involved in redesigning product to minimize its physical size, which resulted in improved performance
• Advanced third-party, LabVIEW tester, preparing it for use in manufacturing environment

Confidential - Arden Hills, MN

Senior Electrical Engineer / Project Manager

Responsibilities:

• Conducted structured complaint investigations to identify and correct performance deficiencies
• Prepared testing protocols and reported on results of field return issues
• Devised creative methods to assist in evaluating returned infusion pumps, to successfully recreate failures observed in the field
• Member of Technical Review Team that defined product life cycle testing expectations and directed-activities
• Reviewed DHF, and performed associated QA activities to sustain legacy products
• Utilized Environmental Stress Screening (ESS) tools to recreate field errors on returned products
• Utilized Design Input documents (DID) to assess performance on field returns
• Used Telelogic DOORS to create specification documents and manage revisions on new product development
• Applied ISO 14971 standard to address Risk Management issues and create performance attributes
• Used pareto charting method to demonstrate historical performance trending results and guide activities
• Created an embedded Assembly/C utility to mine pump Error Code data on a Motorola 68HC11 microcontroller; which was used to assist in Root Cause Corrective Actions (RCCA) on returned products, and development of an alternate methodology to program pump software for manufacturing
• Performed electrical simulations using PSPICE and ngspice to accelerate circuit development
• Involved in selection of a 3rd party electrical design company to advance departmental profitability
• Utilized OrCAD to redesign systems to overcome obsolescence and performance issues and prolong product life
• Visited Confidential, UK to perform a DHF Confidential Gap Analysis on legacy large-volume pumps using the EN 60601-1 standard, to lengthen product lifespan

Confidential - Burnsville, MN

Manufacturing and Development Engineer

Responsibilities:

• Analyzed customer complaints, evaluated returned products, determined associated root causes, and implemented appropriate corrective actions to improve product reliability
• Modified manufacturing documents to meet changing customer requirements resulting in the continued compliance to FAA guidelines
• Applied MIL-STD-810 (Environmental) and -461 ( Confidential ) to ensure performance compliance with FAA requirements
• As part of product development, utilized Highly Accelerated Life Testing (HALT) and Highly Accelerated Stress Screening (HASS) methodologies to improve product performance and reliability
• Created automated trend analysis tool in Matlab, to improve FA processing efficiency
• Performed statistical study to streamline nth-order Pressure Sensor compensation measurements
• Designed and implemented a fixture to overcome ergonomic manufacturing problem for Continuous Improvement program
• Applied Kaizen, Kanban and 5S strategies to improve manufacturing environment

Confidential - Bloomington, MN

Product and Test Engineer

Responsibilities:

• Responsible for creating and implementing C test programs to validate product performance and analyze deficiencies; tracing them to a process step, and recommending changes to process engineers
• Created 2-dimensional wafer bitmapping analysis tool that resulted in the ability to trace performance back to a reticle field; which improved efficiency in process failure analysis
• Received patent for designing and implementing an equipment improvement that resulted in a 10% financial savings on several products and improved efficiency in wafer sort time