About Us
Expert engineering & quality systems for medical molding
Injection Molding, Quality Systems & Operations | 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 provide end-to-end support across manufacturing engineering, quality systems compliance, process excellence, and facility design — including advanced smart manufacturing and data analytics capabilities when your operation is ready to scale.
Areas of Expertise
Core Technical & Regulatory Expertise
Our consulting comes from real-world manufacturing experience — not just theory. Because we've run injection molding operations, led quality organizations, and validated processes, our advice fits how a regulated plant actually works.
- Scientific Molding Methodology
- Design of Experiments (DOE) studies
- Process validation (IQ/OQ/PQ)
- Equipment & mold qualification
- Process window development & optimization
- ISO 13485 Quality Management System implementation
- FDA 21 CFR Part 820 / QMSR compliance programs
- Design controls & risk management (ISO 14971)
- Computer Software Assurance (CSA) implementation
- Audit preparation (FDA, Notified Bodies)
- Process optimization & continuous improvement
- Lean manufacturing & Six Sigma programs
- Manufacturing cost reduction strategies
- Production capacity planning & scaling
- Defect analysis & root-cause investigations
- Greenfield & brownfield facility planning
- Cleanroom design & classification (ISO 7/8)
- Global supplier quality & supply chain strategy
- IIoT data foundation & connectivity
- Preventive & predictive maintenance programs
Career Journey
Professional Background
Our founder's career spans six progressive roles across manufacturing engineering, quality, design assurance, and R&D — the cross-functional experience that sets SIDEC Consulting apart.
Current
Associate Director, Manufacturing Engineering
USA Molding Operations
Leading manufacturing engineering for domestic injection molding operations, overseeing process development, equipment qualification, and continuous improvement initiatives across multiple production facilities.
Technical Expert
Principal Engineer, Manufacturing Engineering
Internal Molding Subject Matter Expert
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.
Manufacturing Leadership
Senior Manager, Manufacturing Engineering
Manufacturing Engineering
Managed cross-functional manufacturing engineering teams, led major process development projects, implemented lean manufacturing initiatives, and drove operational excellence across production lines.
Quality Leadership
Director, Quality
Quality Management
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.
Design Assurance
Senior Manager & Principal Engineer
Design Assurance Quality
Led design assurance activities ensuring product designs met regulatory requirements and manufacturing feasibility. Managed design controls, risk management (ISO 14971), and design transfer processes.
Foundation
Engineering Manager → Project Engineer
Career Foundation
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.
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 run operations, so our advice is grounded in scientific molding and DOE, not theory
Regulatory Compliance
Director-level quality experience means we build quality systems that satisfy FDA, ISO, and EU MDR auditors, keeping you compliant and audit-ready
Operational ROI
We map where improvements pay off and focus on actions that return real value, not just chasing technology trends
Regulatory Expertise
Standards & Certifications
Deep knowledge of global regulatory requirements for medical device manufacturing — and how to validate software and systems under the new FDA QMSR.
Regulatory Experience Includes:
- Process validation & automated inspection under QMSR
- Computer Software Assurance (CSA) for manufacturing systems
- FDA and Notified Body audit preparation
- Change control for validated processes and equipment
- 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
Get Started
Let's Work Together
Whether you are expanding operations, building a quality system, or optimizing your molding process, we bring the hands-on manufacturing experience to make it work.