Principal R&D Engineer with over 30 years of engineering experience, including extensive expertise in medical-device product development. Led design and commercialization of complex Class I, II, and III medical devices and drug-delivery technologies, ensuring compliance with rigorous design controls and risk management standards. Contributed to innovation as inventor on 25 U.S. patents, collaborating with cross-functional teams to drive product success and market readiness.
Overview
2027
2027
years of professional experience
Work History
Lead R&D Engineer | Project Manager
Cook Medical
Bloomington, IN
2024 - Current
Provide senior technical leadership for multidisciplinary Class II and III medical-device programs, serving as the primary engineering resource across product architecture, design reviews, verification strategy, technical risk, and production readiness.
Lead alignment across R&D, Quality, Regulatory Affairs, Manufacturing, Program Management, and executive stakeholders to balance technical, regulatory, patient-safety, manufacturing, and commercial objectives.
Led design reviews and technical decision-making on product requirements, architecture, verification strategy, and production readiness, facilitating successful project outcomes.
Plan and execute design-verification testing, including protocol development, data analysis, traceability, and verification activities supporting regulatory submissions and commercialization.
Advised program leadership on technical risk, development strategy, design controls, ISO 14971 risk management, and commercialization readiness to ensure program alignment with regulatory standards.
Influence portfolio and development decisions through evaluation of emerging technologies, clinical needs, technical feasibility, manufacturability, and commercialization opportunities.
Improve product robustness and manufacturing efficiency through DFM/DFA optimization and proactive resolution of technical risks.
Strengthened engineering capability by mentoring team members, providing technical coaching, conducting design reviews, and implementing risk-management and design-control best practices.
Staff Engineer | Technical Design Lead
ENABLE INJECTIONS
Cincinnati, OH
2019 - 2024
Acted as senior technical authority for strategic pharmaceutical partnerships, providing product-architecture leadership, technical decision-making, and commercialization strategy for wearable drug-delivery platforms.
Shaped platform-integration strategies with global pharmaceutical partners to influence technical direction for future wearable drug-delivery programs.
Directed multidisciplinary product development from concept through commercial launch, including verification, design transfer, manufacturing scale-up, production readiness, and commercialization.
Established risk-management strategies to balance patient safety, regulatory compliance, technical performance, and development timelines in FDA-regulated design-control environments.
Led mechanical design of molded, machined, and assembled components using CAD, GD&T, tolerance stack-up analysis, material selection, DFMA, statistical analysis, risk management, and DOE.
Drove design simplification, manufacturing-readiness, semi-automated production implementation, and scale-up initiatives that increased production capacity by 250%.
Led engineering investigations, root-cause analysis, and corrective actions while collaborating with manufacturing engineering on process development and component modifications.
Built, mentored, and led a team of 5 R&D engineers, strengthening technical capability through coaching, design-review leadership, and engineering standards.
Principal Engineer | Project Team Leader
TYBER MEDICAL
Bethlehem, Pennsylvania
2018 - 2019
Directed development of orthopedic trauma implant and surgical instrument systems from concept through commercialization.
Acted as primary technical interface among executive leadership, customers, suppliers, and cross-functional development teams; advised leadership on go/no-go decisions, technical risk, and portfolio strategy.
Acted as the primary product-development contact with the DePuy product team to align product requirements and technical specifications.
Facilitated design and risk reviews, change control, and corrective actions to address technical and program risks, enhancing project alignment and mitigation strategies.
Coordinated design verification, transfer, manufacturing scale-up, production-readiness assessments, and supplier qualification to ensure successful commercial launch.
Developed and updated 3D CAD models and engineering drawings using GD&T, incorporating tolerance analysis and verification testing to ensure product accuracy and reliability.
Simplified product architectures using DFMA principles to improve scalability, robustness, manufacturing efficiency, and product cost.
Mentored 4 product-development engineers while leading strategic product-development initiatives.
Led development of interventional pain, spinal, implant, and related medical technologies from early concept through commercialization within FDA-regulated design-control environments.
Defined product architecture and commercialization strategy for novel drug-delivery platform, driving alignment with strategic growth initiatives.
Influenced development priorities and investment decisions across embolization systems, vertebral compression-fracture solutions, spinal instrumentation, and implant technologies.
Served as enterprise technical authority across multiple business units, shaping platform strategy, guiding technology investments, and defining long-term product roadmaps.
Invented and developed a custom compassionate-use spinal implant enabling life-saving surgical reconstruction for a two-year-old patient.
Architected complex mechanical systems using tolerance analysis, material selection, risk-based engineering, DFMA, and design-verification methods.
Directed manufacturing transfer, ensured production readiness, managed supplier qualification, facilitated commercial-launch support, and planned lifecycle management.
Collaborated with spinal surgeons and cross-functional teams across Program Management, Regulatory, Quality, Manufacturing, and Product Assembly to translate clinical needs into product requirements and manufacturable solutions.
Senior Staff Product Design Engineer | Principal R
MOTOROLA | AUTOLIV | TRW
U.S. / INTERNATIONAL
1990 - 2010
Held progressive senior engineering roles developing highly regulated electromechanical systems, automotive safety technologies, and global product platforms.
Managed international development teams and supplier collaborations across North America, Europe, and Asia to align with global R&D strategy and drive innovation-roadmap initiatives.
Developed and launched advanced electromechanical systems across automotive and consumer-product industries.
Introduced advanced Degressive Load Limiting and Adaptive Load Limiting retractor safety systems into the U.S. automotive market.
Created market opportunity by introducing electrical locking retractor system for wheelchair restraints, expanding product offerings.
Co-developed a global retractor-system platform during a 3-year expatriate engineering assignment in Germany.
Designed hundreds of complex plastic injection-molded and metal components, mechanisms, and assemblies, enhancing product functionality and manufacturability.
Education
Bachelor of Science - Mechanical Engineering
GMI Engineering and Management Institute
Flint, Michigan
01-1995
Six Sigma / Design For Six Sigma Black Belt
25 U.S. Patents
Skills
Device development
Mechanical design
Design controls
Verification and validation
Risk management
Geometric dimensioning and tolerancing
Design for manufacturability
FMEA & Root Cause Analysis
Lean Product Development
Quality Control Techniques
CAD & Prototyping
Manufacturing scale-up
Production readiness
Supplier & Cross-Functional Leadership
Project leadership
SELECTED CAREER ACHIEVEMENTS
25 U.S. patents spanning drug-delivery devices, combination products, implant systems, surgical instruments, mechanical safety mechanisms, and medical-device platforms.
Increased production capacity by 250% through design simplification, process optimization, semi-automated production implementation, manufacturing readiness, and scale-up initiatives.
Provided senior technical authority for Class II and III medical-device programs, influencing product architecture, verification strategy, technical risk, manufacturability, and commercialization readiness.
Led and mentored a team of 5 R&D engineers, strengthening technical capability through coaching, design reviews, and engineering standards.
Developed a custom compassionate-use spinal implant enabling life-saving surgical reconstruction for a two-year-old patient.
Led product-development and commercialization programs spanning wearable drug delivery, combination products, orthopedic trauma, spinal technologies, interventional pain, surgical instruments, implants, and electromechanical safety systems.
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