Nathaniel Jackson Email & Phone Number

Marlborough, Ma, Us

Waltham, Ma, Us

• Technical lead for successful class III IDE medical device product development, submission, approval and successful clinical trial.• Authored and maintained system requirements, subsystem requirements, and system architecture documentation for multiple products, including definition of functional, organizational and operational architectures using SysML.• Extensive modeling of pneumatic systems in Python, driving architectural and design decisions.• Drove design and architectural decisions through use of Pugh analysis, and other tradeoff analysis tools.• Lead the system development/integration process, including defining the process, organizing cross-functional deliverables, defining test points, and managing prototype configurations in JIRA.• Worked with controls, software, and hardware engineers on development of system algorithms.• Responsible for creation and maintenance of system-level risk documentation including DFMEA and hazards analysis.• Worked with FDA review team to educate them on and defend the technical approach for system operation and verification.• Worked with Chief Medical Officer and key opinion leaders to determine treatment strategy for product.• Analyzed technical standards to determine applicability and testing scope.• Performed initial feasibility and integration testing of prototype to show performance and validate models.• Worked with the Senior Director of Systems Engineering to establish processes and standards for systems engineering deliverables.• Defined methodologies for testing major performance characteristics of the system

Bedford, Ma, Us

• Responsible for functional management of four individual contributors, including goal setting, coaching, annual reviews, and employment decisions.• Lead process for implementing Cognition Cockpit for management of project planning, requirements, verification testing and design reviews.• Responsible for risk management of multiple products including planning, hazard analysis, FMEA, and reporting for multiple products.• Developed and maintained system and subsystem requirements.• Member of the cybersecurity task force for the organization; evaluating current controls, regulatory concerns and determining path forward.• Maintained architecture and specifications for assigned products.• Acted as subject-matter expert during regulatory audits.• Worked extensively with legacy IBM DOORS for risk management, requirements management, and traceability.

Manchester, Nh, Us

• Tasked with determining root cause of anomalies from verification testing, and presenting progress and solutions• Designed experiments to collect data in support of failure analysis• Created Python scripts for analysis of data• Reviewed Final Verification test cases for content and thoroughness, and offered feedback to Test Engineers who authored the tests• Reviewed and dispositioned final test results.• Investigated reported anomalies and determined their validity• Created investigation write-ups, used to disposition existing anomalies• Determined completion of ECO impacts on design documentation, and reported results to lead Systems Integration Engineer• Researched and wrote Safety Assurance Cases• Revised DFMEA for disposable• Remediated linking of requirements between system and subsystem requirements documents• Obtained knowledge of ISO 14971, IEC 60601-1-6, and ANSI/AAMI/IEC 62366-1

Manchester, Nh, Us

• Responsible for reviewing and approving completed Final Verification test results• Gave feedback to Test Engineers and Test Technicians on GDP and content of final test records• Reported status to, and discussed testing strategy with, Validation and Verification Test Manager

Manchester, Nh, Us

• Responsible for the Engineering Verification Testing, performed to ensure successful completion of Qualification Testing• Created the Test Plan to establish the methods and controls for the testing• Assessed testing needs, presented plan to create test team to relieve the burden on the designing engineers, and lead hiring process for needed Test Technicians• Designed testing laboratory, including IT equipment, layout, power requirements and test equipment• Oversaw acquisition of equipment and supplies for testing effort• Worked with a cross-functional team in support of an in-development medical device• Interfaced between Project Manager, Engineering Leads, Test Engineers and Test Technicians• Reported progress to Project Manager, executive management, customer’s engineering team and customer’s executive management• Worked with Engineering Leads to refine requirements documents and test methods• Oversaw creation of testing procedures• Scheduled and assigned work to four Test Technicians, including approval of timesheets• Worked with Systems Integration Engineers and QA Personnel to review test methods and test results• Assigned work to seven engineers, including test method authorship and test execution• Held testing readiness reviews, where I presented pertinent information to the customer, and answered questions• Wrote ECO documents

Manchester, Nh, Us

• Worked with a cross-functional team in support of an on-the-market medical device• Responsible for authoring testing methods based on requirements specification documents• Programmed software tools utilized for qualification testing• Validated in-house and commercial software tools• Responsible for supervising Test Technicians, in the performance of testing methods• Performed Engineering Notebook testing utilizing GDP• Created and revised operating procedures used during Final Verification Testing• Responsible for reviewing the work of peers and for providing feedback to peers• Performed Engineering Verification Testing for an up-coming medical device• Initial investigation of anomalous test results• Participated in interviewing new Test Engineers for other projects• Offered feedback about testability of System Requirements, prompting ECOs of requirements documents• Worked with IEC 60601-1 3rd Edition and particular standards• Authored methods for debugging and testing of embedded software• Ensuring that equipment was used within its appropriate calibration range, and time period

Boston, Ma, Us

Worked in the Bone Cell Biology Laboratory with research fellows and primary investigator to design and perform original research on quantifying osteoclast activity. Learned and utilized aseptic technique for maintaining and experimenting on cell cultures. Developed working protocol for imaging full cell-culture plate well, using ImageAssembler.