Susan Myers
Columbia City
Summary
Holistic Systems Engineer creates solutions designed to integrate seamlessly or serve as foundations for new operations. Provides both functional products and integral documentation. Trusted creator of systems aimed at powering increased revenue and growing profits.
Overview
26
26
years of professional experience
Work History
Systems Engineering Manager
Johnson & Johnson
02.2023 - Current
- Led application of Systems Engineering principles to drive development and maintenance of robotics software, defining architecture and ensuring alignment with system-level objectives.
- Performed Software Systems Engineering for multiple projects/subsystems, translating system requirements into validated software designs and implementation plans.
- Ensured end-to-end interoperability of software components, processes, and systems through integration strategies, verification activities, and acceptance criteria.
- Provided top-down coordination of software subsystems with software systems, hardware, manufacturing, and process teams to align schedules, requirements, and deliverables.
- Addressed trans-disciplinary challenges across functional groups, directing end-to-end software deployment, issue triage, and change-management workflows.
- Authored Software Systems deliverables including software development plans, system descriptions, software release records, unresolved anomaly reports, and release notes.
- Established and defined software systems requirements and interface specifications to ensure clear boundaries and testable acceptance criteria.
- Implemented requirements traceability from upstream system requirements to downstream software subsystem requirements and led associated risk analyses.
- Directed Cybersecurity management activities and artifacts, producing Cybersecurity Management Plans, threat models, risk analyses, and summary reports.
- Championed data management strategy and deliverables to ensure data integrity, accessibility, and compliance across software systems.
- Managed Configuration Management of software, hardware, and process compatibility, maintaining baselines and authoritative documentation.
- Oversaw system-level software development tools, defining tool requirements, authoring work instructions, and integrating tools into engineering processes.
- Drove lifecycle management processes by capturing feedback, leading issue investigations, and implementing corrective/preventive actions.
- Authored and executed change-management deliverables, including Software System Engineering Change Plans, and governed change reviews across stakeholders.
- Led regulatory filing and registration activities for software systems, coordinating documentation and compliance evidence for submissions.
Principal Software Quality Engineer
Johnson & Johnson- DePuy Synthes
12.2017 - 02.2023
- Software Quality Engineering Program Lead for all phases of Medical Device Software development projects
• Responsible to define, implement, coordinate and execute Software Design Control Strategies across a Robotic Assisted Solution Software Platform
• Apply System Engineering approaches and principles for integrating multiple systems, sub-systems, components and process for all phases of Medical device software development projects.
• Responsible to define and establish strategic plans and visions for end-to-end processes for all phases of Medical Device projects and products.
• Provide leadership, train, and direct staff in medical device product development, with a focus on software design controls
• Expertise in and responsible for Design Control documentation and Design History Files to comply with IEC 62304, FDA Guidance, ISO 13485, ISO 14971, and IEC62304
Lead ISO 14971 risk management activities including authoring Risk Management Plans, FMEAs, and Residual Risk Reports
Associate Sr. Consultant Engineer Delivery Device Research and Development
Eli Lilly and Company
01.2013 - 12.2017
- Program Lead and Project Manager for all phases of Medical device development projects
- Responsible for System Engineering and integration of multiple subcomponents for drug delivery systems
- Expertise in and responsible for Design Control documentation and Design History Files to comply with IEC 62304, FDA Guidance, ISO 13485, ISO 14971, and IEC 62366
- Author device related sections of regulatory submissions and support regulatory filings and inspections
- Lead ISO 14971 risk management activities including authoring Risk Management Plans, FMEAs, Safety Assurance Cases, and Residual Risk Reports
- Provide leadership, train, and direct junior staff in medical device product development
- Apply project management skills, and apply appropriate quality systems and processes to effectively develop and execute project plans to meet project goals and objectives
Sr. Project Engineer Delivery Device Research and Development
Eli Lilly and Company
01.2007 - 01.2013
- Lead, plan and manage design control activities for injection pen delivery systems and topical application system
- Utilize statistical techniques and software to analyze data and identify trends
- Author technical protocols, reports, and various regulatory document submission modules (EU, 510(k), NDA, FDA briefing document submissions)
- Coordinate with internal and external business partners to produce prototypes, plan and execute development testing
- Authored Change control and CAPA records
- Experience with laboratory operations including test fixture and equipment design, test method development, GR&R, and test method validation
- Lead Human Factors Engineering activities to comply with FDA guidance documents and IEC 62366
- Conduct Design and Design for Manufacturability reviews
- Mentor summer interns, co-op students and new hire engineers
Process Engineer Pharmaceutical Delivery System
Eli Lilly and Company
01.2004 - 01.2007
- Provided technical support for various process and product improvements for pre-filled pen injectors
- Conducted detailed technical complaint investigations for pre-filled pen injectors
- Authored product, subassembly, and component specifications and drove global harmonization of specifications across multiple manufacturing sites
- Authored Change control and CAPA records
- Performed extensive Statistical Analysis including Design of Experiments
- Trained and qualified new employees to perform detailed complaint investigations
Manufacturing Specialist Diagnostic Division
Abbott Laboratories
01.2002 - 01.2004
- Responsible for the manufacturing and supporting of diagnostic products following GMPs and QMS practices
- Participated in product failure investigations
- Reviewed product protocols for compliance and manufacturability
- Designated as an ‘On The Job Trainer’ for new employees
- Recommended and justified change requests to improve manufacturing instructions
- Achieved excellent quality rating
Field Trial Research Scientist Intern
Dow AgroSciences
06.2001 - 09.2001
- Worked in a team setting to conduct product development research
- Conducted GLP and safety audits
Summer Research Scientist Intern
Syngenta Crop Protection
06.2000 - 09.2000
- Managed field trials and evaluated chemical performance for product development
Education
Master of Science - Engineering
Purdue University
West Lafayette, IN12-2021
Bachelor of Science - Biology
Purdue University
West Lafayette, IN12.2001
Skills
- Superior knowledge of EU, FDA QSR/ISO 9001 device design control regulations
- Superior knowledge of Quality Management Systems
- Systems integration
- Lean Six Sigma Green Belt Certification
Configuration management
- Technical leadership
Timeline
Systems Engineering Manager
Johnson & Johnson
02.2023 - Current
Principal Software Quality Engineer
Johnson & Johnson- DePuy Synthes
12.2017 - 02.2023
Associate Sr. Consultant Engineer Delivery Device Research and Development
Eli Lilly and Company
01.2013 - 12.2017
Sr. Project Engineer Delivery Device Research and Development
Eli Lilly and Company
01.2007 - 01.2013
Process Engineer Pharmaceutical Delivery System
Eli Lilly and Company
01.2004 - 01.2007
Manufacturing Specialist Diagnostic Division
Abbott Laboratories
01.2002 - 01.2004
Field Trial Research Scientist Intern
Dow AgroSciences
06.2001 - 09.2001
Summer Research Scientist Intern
Syngenta Crop Protection
06.2000 - 09.2000
Master of Science - Engineering
Purdue University
Bachelor of Science - Biology
Purdue University