25 plus years of medical, quality, process, management experience. Proven results with small start-up companies to attain ISO Certification. His team develops a partnership to improve businesses to be more profitable, compliant and growing primarily in the medical device industry. Steve leads a great team of individuals in their network to solve most issues constraining a business. SIGMA’s continued growth keeps expanding services to the industry.

30 years in the Medical Device Industry having worked in many roles including manufacturing engineering, product development and business owner. His primary focus over the past 12 years has been to the supplier for validation, lean manufacturing and ISO 13485 compliance and through that experience gained valuable knowledge and trust with many of the large and small contract manufacturers.

25 plus years of Medical Device/Regulatory, quality, management experience. Strong background with proven results with small start-up companies to attain FDA 510K clearance, ISO Certification. Global marketing.

20 plus years of medical, quality, process, management experience. Certified-Lead Auditor ISO 13485:2016, QSIT, QSR, MDD, CMDR, Risk Management, Process Validation, Process Mapping, Corrective and Preventative Action. Proven results to manage projects for medical device companies to successful completion.

15 plus years working in the Medical Device/ Pharmaceutical Industry. Strong Regulatory and Quality background in New Product Introduction, CAPA Systems, process validation, FDA remediation, Risk based Supply Chain management, Purchasing Controls, Change Control and Lean/6 Sigma Black Belt/ Continuous Improvement projects, packaging, product risk management. Certified ISO – 13485 RAB- Lead Auditor.

17 Years’ of quality and regulatory experience in Medical Device, Automotive and Electronics. Skilled in QMS systems development and auditing to national and international standards. 10 years’ experience designing and executing equipment and process validations to meet ISO and FDA standards. Background in risk management, CAPA, FDA audits, and MSA. Certified ISO 13485 Lead Auditor.

Over 25 years experience in the medical industry with experience in Process, Quality, and Supplier Quality Engineering. Certified Lead Auditor for ISO 13485:2016. Experienced in Corrective Actions, Validations, Supplier Change Requests, gage design, Geometric Dimension and Tolerancing and product transfer.

Over 25 years in Quality Engineering in Medical Device with strengths in assessment and development for Design, Process, Software, Sterile, and Packaging of Medical Devices. Experience includes Implantable medical devices, electromechanical manufacturing and software integration Risk Management. Formally trained in Design for Reliability and Design for Manufacturing, which includes Design History File Requirements, Project Management, Supplier Quality Development and Design Transfer, Post Market Monitoring and Reporting. Coached Corrective Action Preventative Action compliance, cause analysis, corrective action methods, and effectivity risk evidence analysis per ISO14971. RAB certified Lead Auditor for ISO 13485, 2016.

17 years of medical device experience for quality management system and regulatory compliance. Certified ISO auditor ISO 13485:2016 and ISO 9001:2015 for AB Certification (registrar base in Paris, France). Certified Lead Auditor ISO 13485:2016 and ISO 9001:2015..CE MDR compliance (device classification, Declaration of conformity and Technical file requirements). FDA compliance to QSR, QSIT. FDA 510K clearance, PMA clearance, device classification, registration, and listing. MDSAP compliance.Risk management process according to ISO 14971:2019 / ISO 24971:2020. Supplier audit and control of suppliers. Process mapping, Corrective and preventive action. Proven results to manage projects for medical device companies to successful completion of compliant quality system and documentation for ISO certification, FDA compliance, and CE marking certification.

An adaptable, versatile Product Development professional with proven results in new Medical Devices, research and development, and regulatory compliance. Excellent communicator adept at establishing relationships both internally and externally. Strong technical expertise and leadership abilities that contribute to product innovation and quality improvements for a wide range of products and applications. Demonstrated ability to multi-task and work under pressure while balancing priorities. Proven ability to quickly develop and apply a broad knowledge base. More than 25 years experience as Mechanical Engineer, Designer, Project Leader and Director within medical device industry. Technical strengths encompass design of implants and instruments for orthopedic applications.

Over 30 years Manufacturing Operations and Manufacturability Design, Product Development and Process Redesign and Project and Program Life Cycle Management for both medical devices and instruments manufacturing, Class I & II devices. Led total process of device and instrument development, manufacturing, costing, and continuous improvement; led teams as large as 75. 2013 Infinity Award winner for developing comprehensive Design for Reliability Manufacturability (DRM and DRMA) toolbox, enabling complete product manufacturing review down to feature level by integrating product manufacturing, inspection and characterized cost while assuring comprehensive feedback to product development teams. An inventive and accomplished medical device and biologic device manufacturing process professional, awarded 13 medical patents. Master Validation plan, Facility and Process validation expert, CFR 820, ISO 13485:2016, establish quality levels – 5S/6S, lean, and Pareto analysis, plus others. Multiple CEA and Clean Room installations, Multiple Water System installs and validations, Cleaning validation expert, Class I & II devices. CAPA and Root Cause expert. Lean Manufacturing, Six Sigma and Shainin® Statistical Engineering.

Over three decades of dedicated service in the medical device industry, I am a seasoned professional with multifaceted expertise, having navigated various pivotal roles encompassing manufacturing, engineering, and product development. I have amassed invaluable insights into the intricacies of the field. Throughout my career, I have been instrumental in ensuring compliance with ISO 13485 and 9001 standards, spearheading quality management systems. I possess an innate knack for identifying areas of improvement and implementing robust corrective and preventive actions to uphold the highest standards of quality and safety. Known for my unwavering commitment to excellence.