Sulaiman H.

About Sulaiman H.

Medical Device Leader with 16+ years of experience uniquely bridging design, manufacturing & combination-product development—a rare & highly impactful blend in regulated high-risk medical technologies. I bring deep hands-on expertise across the full product lifecycle, from core technology invention & early R&D through process development & global scale-up.Started as a manufacturing engineer on the production floor, a foundation that continues to shape how I design products today—with a focus on DFM/A & real-world performance. Over the years, I have held progressively senior roles across Process Development, New Product Introduction (NPI), Core R&D & high-volume manufacturing, delivering Class I, II & medical devices.Combination Products & Breakthrough TechnologiesI have led core technology development for breakthrough drug-coated stapler platforms used in thoracic cancer surgeries. This work required tight integration of R&D, materials science, drug–device interactions & process development, translating innovation from concept to validated manufacturing. My experience spans drug-coated stents, flow-modulation stents, meshes, stapling systems, proprietary coating technologies & robotic surgical platforms.Design → Manufacturing → ScaleI have planned & led major engineering programs associated with final product assembly, with hands-on involvement in testing, commissioning, validation & regulatory readiness. I have led manufacturing transfers & production scale-up at contract manufacturers inside & outside the U.S. Also established global supply chains supporting IDE builds & commercial launchesLeadership & Global ImpactI am a people-centric, results-driven leader known for building high-performing cross-functional teams while balancing risk, speed, compliance & business outcomes. As Medtronic’s Global Innovation Fellow, I led a team that delivered a 5-year strategic plan for the Ramakrishna Mission in Fiji—engaging stakeholders from rural communities to the Ministry of Health & the Prime Minister of Fiji, presenting insights to Medtronic CEO Omar Ishrak & identifying opportunities for Medtronic’s expansion in developing markets.What Defines My EdgeA rare combination of design depth, manufacturing rigor & combination-product expertise, with a proven ability to translate complex R&D into scalable, compliant & commercially viable systems across minimally invasive implantable medical devices, robotics & global health initiatives.

Experience

1. Staff Research & Development Lead

   Johnson & Johnson MedTech

   May 2021 — Present

   Leading development of next generation robotic endoscope, establish CMs, and full global supply chain to deliver devices beyond IDE, limited market release and full market release Led design & development of instruments & Accessories, highly articulated tools (HATs), on state of the art robotic surgery platform, for laparoscopic, endoscopic and adjunct surgeries Led different coating projects for the surgical instruments for various proprietary applications Led scale up initiatives of production at contract manufacturers(CMs) within & outside the US Drove gross profit (GP) improvement initiatives across the HAT platform to ensure successful commercialization efforts

Education

• University of Michigan - Rackham Graduate School

  Master's degree in Engineering, Mechanical Engineering

• Project Management Institute

  Project Management Professional (PMP)

• IIUM

  B.Eng, Mechatronics Engineering

• Indiana Wesleyan University

  Master of Business Administration - MBA

Skills

• 5s
• Ultrasonic Welding
• Design of Experiments
• Manufacturing
• Design Expert
• Dfmea
• Simulink
• Gmp
• Matlab
• Medical Devices
• Sipoc
• Capa
• Project Management
• Solidworks
• Validation
• Process Capability
• Process Modeling
• Public Speaking
• New Program Launches
• Pfmea
• Lean Manufacturing
• Pmp
• Minitab
• Cgmp Manufacturing
• Ms Project
• Six Sigma
• Toc
• Quality System
• V&V
• Extrusion
• Scientific Molding
• Silicone Molding
• Value Stream Mapping
• Anova
• 21 Cfr Part 11
• 5 Why
• Igrafx
• Simulations
• Xml
• Measurement System Analysis