Business Details
Expert Mechanical Engineering for Medical Manufacturing
With over two decades of specialized experience in medical device manufacturing and development, I bring a data-driven, technically rigorous approach to process engineering and innovation. My career at Boston Scientific Corporation spanned 20 years, where I led validation activities, implemented Six Sigma methodologies, and transitioned laboratory prototypes to scalable production. Holding a Bachelor of Engineering in Mechanical Engineering from the University of Guelph, I combine technical expertise in statistical analysis, equipment validation, and quality assurance with hands-on problem-solving skills.My work has consistently reduced manufacturing scrap, improved product yield, and ensured compliance with FDA and DEKRA regulatory standards. As I complete my transition to Canada, I seek opportunities to apply my proven track record in process optimization and cross-functional collaboration to advance medical manufacturing excellence.
Services
Process Development
Statistical Analysis
Six Sigma Methodology
Medical Device Manufacturing
Equipment Validation
Quality Assurance
Production Optimization
Regulatory Compliance
Highlights and features
- We offer 20+ years of FDA-regulated medical manufacturing expertise.
- Our team specializes in Six Sigma and statistical process optimization.
- We provide proven solutions for reducing production scrap and downtime.
- Our approach ensures compliance with DEKRA and FDA quality standards.
- We transition R&D concepts to scalable, high-quality production.
Services
Process Development
Develop scalable manufacturing processes for medical devices, ensuring quality and efficiency. Utilize Six Sigma to reduce waste and improve yield. Collaborate with R&D teams to transition prototypes to production.
Statistical Analysis
Apply Minitab and R software to analyze production data, identify trends, and optimize equipment performance. Implement data-driven solutions for consistent quality and regulatory compliance.
Equipment Validation
Create validation protocols for manufacturing equipment, including calibration and qualification. Ensure systems meet FDA standards and maintain documentation for audits and compliance.
Quality Assurance
Monitor production to uphold Good Manufacturing Practices. Conduct failure mode analysis and implement corrective actions to maintain high-quality output and regulatory adherence.
Production Optimization
Identify and resolve production bottlenecks using root cause analysis. Improve throughput and reduce downtime through equipment upgrades and process adjustments.
People
Michael D. Porter
Mechanical Engineer
20-year veteran in medical device manufacturing with expertise in Six Sigma, statistical analysis, and FDA compliance. Holds a Bachelor of Engineering from the University of Guelph and a minor in Statistics.
Questions
What industries do you specialize in?
I specialize in medical device manufacturing, with expertise in process engineering and FDA-regulated quality assurance.
What services do you offer?
I provide process development, statistical analysis, Six Sigma implementation, equipment validation, and production optimization for medical manufacturing.
Are you currently available for hire?
Yes, I am actively seeking roles in the Greater Toronto Area focused on mechanical engineering and manufacturing improvement.
What certifications do you hold?
I am Six Sigma certified and have extensive experience with FDA, DEKRA, and ISO quality standards.
Can you work with regulatory compliance?
Yes, I have 20 years of experience ensuring compliance with FDA, DEKRA, and Good Manufacturing Practices.
What tools do you use for analysis?
I utilize Minitab, R Statistical software, and Six Sigma methodologies for data-driven process improvements.
