About Us
The rare team that can deploy AI and survive the audit
Injection Molding × Applied AI | 25+ Years Experience
SIDEC Consulting brings over 25 years of hands-on experience in medical device injection molding — scientific molding, DOE, process validation, and ISO 13485 quality systems, across leadership roles from Project Engineer to Associate Director.
We now use that foundation to bring AI and machine learning onto the molding floor responsibly — process optimization, quality and inspection, predictive maintenance, and the validation and governance that lets you deploy AI in a regulated plant and defend it in an audit.
Areas of Expertise
Domain Depth, Now Applied to AI
Our AI work comes from real-world manufacturing experience—not a data-science lab. Because we've run injection molding operations, led quality organizations, and validated processes, the AI we deploy fits how a regulated plant actually works.
- Scientific Molding Methodology
- DOE accelerated & extended with machine learning
- ML surrogate modeling (predicting quality from parameters)
- Closed-loop / adaptive process control
- Multi-objective optimization: cycle time, scrap, energy & quality
- ML validation under ISO 13485 & FDA QMSR
- Computer Software Assurance (CSA) for AI systems
- Explainable AI (XAI) for auditable models
- Model lifecycle governance: versioning, drift, retraining
- ISO 14971 risk management extended to AI failure modes
- Vision-based defect detection (short shots, sink, warpage, flash)
- Predictive defect models & early-warning systems
- Build-vs-buy evaluation and QMS integration
- AI-assisted CAPA & nonconformance pattern analysis
- Process validation (IQ/OQ/PQ) & statistical process control
- Predictive maintenance (sensor strategy, models, ROI realism)
- IIoT architecture & the data foundation AI requires
- OEE / scrap / energy analytics & dashboards
- LLM operator assistants to capture tribal knowledge
- Supplier quality, technology transfer & facility design
Career Journey
Professional Background
Our founder's career spans 6 progressive roles across manufacturing engineering, quality, design assurance, and R&D—providing the cross-functional expertise that sets SIDEC Consulting apart.
Leading manufacturing engineering for domestic injection molding operations, overseeing process development, equipment qualification, and continuous improvement initiatives across multiple production facilities.
Served as the organization's go-to expert for injection molding challenges, providing technical guidance on scientific molding, process validation, tooling optimization, and troubleshooting complex manufacturing issues.
Managed cross-functional manufacturing engineering teams, led major process development projects, implemented lean manufacturing initiatives, and drove operational excellence across production lines.
Directed quality management systems, led FDA and Notified Body audit preparations, managed CAPA programs, and ensured compliance with ISO 13485, FDA 21 CFR 820, and EU MDR requirements.
Led design assurance activities ensuring product designs met regulatory requirements and manufacturing feasibility. Managed design controls, risk management (ISO 14971), and design transfer processes.
Built foundational expertise through progressive roles: Engineering Manager leading technical teams, Project Manager driving cross-functional initiatives, and Project Engineer developing hands-on manufacturing skills.
Education
Academic Foundation
Strong academic credentials in chemistry and plastics engineering provide the scientific foundation for our technical expertise.
M.Sc. Organic Chemistry
Polymer Specialization
Advanced studies in organic chemistry with specialization in polymer science, providing deep understanding of material properties, polymer processing, and chemical interactions critical to injection molding manufacturing.
PG Diploma in Plastics Engineering
Plastics Processing & Engineering
Comprehensive training in plastics processing technologies, mold design, material selection, and manufacturing engineering principles essential for injection molding excellence.
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Learn More About Us
Interested in learning more about our background and qualifications? Schedule a consultation to discuss how we can help your organization.
What Sets Us Apart
Cross-Functional Expertise
Unlike consultants who specialize in just one area, our founder's career spans manufacturing, quality, design assurance, and R&D—enabling us to see the full picture and deliver solutions that work across your organization.
Molding-Floor Credibility
From Associate Director to Project Engineer—we've actually validated processes, so our AI is grounded in scientific molding and DOE, not theory
Audit-Survivable AI
Director-level quality experience means we validate ML under ISO 13485/QMSR and document it to satisfy FDA, ISO, and EU MDR auditors
ROI Realism
We map where AI pays off and where it's premature—so you invest in the sensors and models that return, not the hype
Regulatory Expertise
Standards & Certifications
Deep knowledge of global regulatory requirements for medical device manufacturing — and how to deploy AI/ML inside them under the new FDA QMSR.
Regulatory Experience Includes:
- Validating AI/ML process control & inspection under QMSR
- Computer Software Assurance (CSA) for AI-enabled systems
- FDA and Notified Body audit preparation
- Predetermined Change Control for models that retrain
- 510(k) support, EU MDR technical files & CAPA systems
Philosophy
Our Consulting Approach
Every engagement is guided by core principles that ensure lasting value for your organization.
“Our goal is not just to solve your immediate challenges, but to build capabilities within your organization that drive continuous improvement long after our engagement ends.”
— SIDEC Consulting
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Let's Work Together
Whether you're exploring where AI fits or ready to validate a model for production, we bring the molding-floor experience to make it work — and survive an audit.