Your Manufacturing Excellence Partner
Medical Device Manufacturing Experts | 25+ Years Experience
SIDEC Consulting brings over 25 years of hands-on experience in medical device manufacturing. Our founder has held leadership positions from Project Engineer to Associate Director, building deep expertise across manufacturing engineering, quality systems, design assurance, and R&D.
This unique cross-functional experience—spanning injection molding operations, quality management, design controls, and product development—enables us to understand your challenges from multiple perspectives and deliver comprehensive solutions that work.
Deep Technical Knowledge
Our expertise comes from real-world experience—not textbooks. From running injection molding operations to leading quality organizations to directing R&D teams, we've done the work and know what it takes to succeed.
- Scientific Molding Methodology
- Process Development & Validation
- Design of Experiments (DOE)
- Automation & Robotics Integration
- Material Selection & Compatibility
- ISO 13485 Quality Systems
- FDA 21 CFR Part 820
- EU MDR (2017/745)
- MDSAP Compliance
- 510(k) Submissions
- Process Validation (IQ/OQ/PQ)
- Risk Management (ISO 14971)
- Design Controls
- Statistical Process Control
- Root Cause Analysis
- Supplier Quality Management
- Global Supply Chain Strategy
- Technology Transfer
- Due Diligence & M&A Support
- Facility Design & Build
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.
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 medical device 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.
Learn More About Us
Interested in learning more about our background and qualifications? Schedule a consultation to discuss how we can help your organization.
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.
Manufacturing Engineering Excellence
From Associate Director to Project Engineer—deep hands-on expertise in injection molding, process development, and operational excellence
Quality & Regulatory Leadership
Director-level experience building and managing quality systems that satisfy FDA, ISO, and EU MDR requirements
Design Assurance & R&D
Principal Engineer and Director experience ensuring designs are manufacturable, compliant, and optimized for production
Standards & Certifications
Deep knowledge of global regulatory requirements for medical device manufacturing and quality management systems.
Regulatory Experience Includes:
- 510(k) submission preparation and support
- EU MDR Technical File development
- FDA and Notified Body audit preparation
- Quality system gap assessments
- CAPA and complaint handling systems
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