Quality · Engineering · Consulting
18+ years delivering quality systems, regulatory strategy, and engineering solutions for medical device and manufacturing companies.
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SIF Engineering is the consulting practice of EJ Spofford — a hands-on engineering and quality leader who has spent nearly two decades solving hard problems for medical device and manufacturing companies. From ISO 13485 certification to cleanroom buildouts, from product design to regulatory remediation, SIF brings senior-level capability without the overhead.
Services
QMS development and implementation, ISO 13485 registration, internal and supplier auditing, CAPA management, and complaint handling — built for real-world compliance.
FDA 21 CFR 820, EU MDR, MDSAP, and MDD remediation. DHF buildout, risk management per ISO 14971, and regulatory submission support.
Concept through commercialization for electromechanical and medical devices. Design for manufacturing, prototyping, CAD/CAM, and 3D printing.
Manufacturing process development, validation (IQ/OQ/PQ), tooling and fixturing design, injection molding optimization, and production scale-up.
Cleanroom design, construction, and qualification (ISO 7/8). Facility buildouts, equipment commissioning, and controlled environment manufacturing.
Supplier management, MRP implementation, Six Sigma process improvement, SOP development, and manufacturing transfer coordination.
Credentials
ISO 9001 & 13485 Lead Auditor · ISO 19011 · ISO 14971 Risk Management · ISO 14644 Cleanrooms
21 CFR Part 820 · EU MDR · MDSAP · MDD · GMP · GCP · GDP · CQV
Six Sigma Green Belt · LEAN Certified · 5S · Continuous Improvement · Operational Excellence
CAD/CAM · 3D Printing · Injection Molding · Cleanroom Design & Manufacturing
BS Engineering, Worcester Polytechnic Institute — Concentration in Manufacturing
Steris/Micro-Clean Pharmaceutical Cleanrooms · HEPA Filter Testing (ISO 14644)
Select Experience
Complaint and CAPA remediation, DHR review, manufacturing process improvements, and quality system stabilization for ISO 13485 compliance.
Full product redesign — battery-powered system with 32dB noise reduction, custom PCB and embedded controls, manufacturing transfer to overseas production partner.
Led ISO 13485 certification from scratch with zero non-conformities. Built the QMS, managed cleanroom construction, and coordinated all regulatory audits.
Managed MDR remediation across 20,000 orthopedic catalog items with a 99% first-pass approval rate and zero production delays.
11-year tenure building cleanrooms, scaling pilot lines to full production, driving $2M in annual savings, and solving critical supplier and process challenges.