Joseph Augustine
Denver,CO
Summary
Accomplished Senior Mechanical Engineering Manager with 20 years in medical device design, manufacturing automation, and defense systems. Led multidisciplinary teams in delivering regulatory-compliant products through effective product development and system integration. Specializes in design for manufacturability, precision tooling, and process validation, translating business objectives into actionable technical roadmaps.
Overview
21
21
years of professional experience
Work History
Owner & Founder
Nizhoni Engineering, LLC
Denver, CO
09.2024 - Current
- Founded and led engineering firm specializing in concept design, prototyping, and production, delivering innovative solutions for diverse client needs.
- Managed daily operations and strategic planning for engineering projects.
- Oversaw project timelines and managed client communications effectively.
Director, Product Development Engineering
3D Systems
Littleton, CO
09.2024 - 06.2025
- Directed multiple engineering and applications teams responsible for additive manufacturing process development, customer integration, and cross-industry technical support.
- Managed team performance, training, staffing, and workload balancing for 30+ concurrent customer programs, enhancing operational efficiency.
- Collaborated with BD, Quality, and Manufacturing Engineering to evaluate feasibility, risk, and ROI of new product initiatives.
- Delivered program status updates and technical briefings to executive leadership, ensuring alignment on project progress and strategic goals.
- Improved documentation turnaround time by 35 % through templated validation protocols.
- Built a structured mentorship program to elevate junior engineers and improve cross-functional collaboration.
- Oversaw budget allocations to ensure optimal resource distribution across various projects.
- Developed and implemented training programs, enhancing team skills and supporting professional growth.
Senior Engineering Manager, Systems Engineering
Terumo BCT
Denver, CO
01.2022 - 09.2024
- Directed systems engineering for high-complexity medical device platforms, leading a team of engineers through all stages of the design-control process.
- Managed multidisciplinary teams responsible for requirements definition, system architecture, verification, and validation.
- Led risk management reviews, DFMEA/PFMEA workshops, and mitigations across subsystems.
- Managed documentation quality, design transfer, and supplier qualification to support compliance and product integrity.
- Coordinated engineering change orders and lifecycle management for released systems.
- Acted as technical liaison among R&D, operations, regulatory, and marketing to ensure alignment on project goals.
- Cultivated culture of disciplined problem solving and traceable documentation to enhance team accountability and project transparency.
Engineer-5, Sustaining Integration Lead
Terumo BCT
Denver, CO
01.2021 - 01.2022
- Chaired triage and prioritization board managing 200 sustaining projects annually (~$19 M portfolio).
- Developed Power BI dashboards to provide executives with integrated cost, quality, and resource data.
- Enhanced project transparency and streamlined backlog management through structured governance.
Engineer-4, Product Development (New Market Entry)
Terumo BCT
Denver, CO
11.2019 - 01.2021
- Created CFD and transient heat-flow models optimizing component temperature distribution.
- Led thermal and flow testing, enhancing data accuracy with 40+ thermocouples and anemometers.
- Resolved vibration and acoustic noise issues through damping and rebalancing strategies (97 % reduction in audible output).
- Designed, executed, and documented verification and validation tests with formal IQ/OQ/PQ protocols.
- Cultivated high-performing team culture, fostering ownership, traceability, and continuous learning.
- Received recognition from VP-level leadership for effective communication and collaboration across departments.
Principal Mechanical Engineer, R&D / New Product Development
Machine Solutions Inc. / Vante
Denver, CO
09.2011 - 10.2018
- Led mechanical engineering efforts for custom medical automation systems integrating RF energy, thermal management, and motion control.
- Managed concept-to-launch execution for multimillion-dollar capital equipment.
- Delivered multiple $1 M–$2 M automation systems on time with zero post-installation failures.
- Managed multiple concurrent projects, streamlining schedules, budgets, and resource assignments for optimal execution.
- Spearheaded design-for-serviceability initiatives improving uptime and maintenance efficiency.
- Designed high-precision assemblies using SolidWorks with strict GD&T and tolerance optimization.
- Developed tooling and fixturing for catheter manufacturing and bonding applications.
- Standardized documentation and drawing practices, reducing design release cycle by 30 %.
- Standardized documentation and drawing practices, reducing design release cycle by 30 %.
- Recognized as an internal SME for RF heating and catheter manufacturing process design.
Senior Mechanical Engineer, Project Investigator, Integrated Weapons Systems
Orbital ATK
Mesa, AZ
05.2009 - 12.2011
- Led mechanical design, integration, and validation for the link-fed variant of the 30 mm Chain Gun under a $5 M DoD program.
- Directed design, analysis, and endurance testing per ASME Y14.5 and MIL-STD documentation standards.
- Managed cross-disciplinary team to coordinate design, procurement, and testing logistics, ensuring project alignment with program goals.
- Ensured ITAR compliance, export control documentation, and secure data handling.
- Presented program reviews to U.S. Army and program office representatives.
- Delivered performance improvements that enhanced weapon reliability and significantly reduced component fatigue, contributing to overall system effectiveness.
- Authored verification test reports and work instructions supporting government acceptance.
- Created FMEA and fault-tree documentation that ensured compliance with safety and redundancy requirements, supporting successful program validation.
R&D Lead Engineer
Sebra Engineering & Research Associates
Tucson, AZ
05.2005 - 05.2009
- Led research, design, and development for blood-collection and medical devices including radiation-treatment and insulin-delivery systems.
- Oversaw product lifecycle from concept to release, ensuring alignment with regulatory standards and market needs.
- Directed multidisciplinary teams in prototyping, design optimization, and risk evaluation.
- Coordinated documentation for FDA submission and ISO 13485 compliance, facilitating regulatory approval and market entry.
- Managed supplier relationships, design verification, and risk mitigation.
- Delivered over $85 M in product revenue with zero recalls across the Saffire and Ruby product lines.
- Authored work and assembly instructions, test protocols, and user training materials to enhance user understanding and compliance.
Education
Bachelor of Science - Mechanical Engineering
University of Arizona
Tucson, AZ01.2005
Skills
- Product innovation
- Prototype development
- Product validation
- Verification testing
- Root-cause analysis
- Risk management
- Design for Manufacturability
- Tolerance optimization
- Sustainability practices
- Systems integration
- CAD & Design Tools
- Testing & Analysis
- Manufacturing & Prototyping
- Quality & Regulatory
- Executive-level communication
- Cross-functional leadership
- Leadership and Management
- Staff development
- Mentoring
- Performance management
- Resource allocation
- Scheduling
- Supplier relationship management
- Budget control
- Manufacturing & Prototyping
- Quality & Regulatory
Websites
Additional Information
U.S., None currently held (ITAR-compliant project experience), Denver area, hybrid or onsite preferred, Strategic leader, Decisive under pressure, Technically rigorous, Highly collaborative communicator, 3D printing (FDM and resin), casting, molding, laser cutting, Arduino development, woodworking, beekeeping, family outdoor activities
Patents
- Method for Controlling RF Energy, US8865035B2, 10/21/14
- Apparatus for Severing and Collecting, US8469690B2, 06/25/13
- RF Generator with Multiplexed Output, US8469688B2, 06/25/13
- Method for Collecting Fluid Samples, US8029712B2, 10/04/11
- Method for Rapidly Heating and Cooling, US7744805B2, 06/29/10
- Apparatus for Rapidly Heating and Cooling, US7438548B2, 10/21/08
Accomplishments
Published Children's Book Author, 2025 Tangible Tales
Timeline
Owner & Founder
Nizhoni Engineering, LLC
09.2024 - Current
Director, Product Development Engineering
3D Systems
09.2024 - 06.2025
Senior Engineering Manager, Systems Engineering
Terumo BCT
01.2022 - 09.2024
Engineer-5, Sustaining Integration Lead
Terumo BCT
01.2021 - 01.2022
Engineer-4, Product Development (New Market Entry)
Terumo BCT
11.2019 - 01.2021
Principal Mechanical Engineer, R&D / New Product Development
Machine Solutions Inc. / Vante
09.2011 - 10.2018
Senior Mechanical Engineer, Project Investigator, Integrated Weapons Systems
Orbital ATK
05.2009 - 12.2011
R&D Lead Engineer
Sebra Engineering & Research Associates
05.2005 - 05.2009
Bachelor of Science - Mechanical Engineering
University of Arizona