Jacob Mathai Email & Phone Number

Carlsbad, CA, US

• Collaborated with prominent medical device and pharmaceutical companies on international compliance and quality drives, leveraging engineering acumen to cultivate and maintain Class II and III medical devices.
• Deliver ongoing support and guidance to clients throughout product lifecycle, from development to post-market surveillance, while constantly training internal teams and stakeholders on compliance requirements and best.
• Specialties include Project Management, Supplier Development, Process Improvements, Process Development, Launching New products, Cost reductions

Los Altos, US

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South San Francisco, California, US

• Built a global team of experts through strategic recruiting, coaching and mentoring in process development, packaging, project management, device engineering, and contract engineering to optimize efficiency
• Enabled seamless global collaboration with CMOs and internal manufacturing sites, steering end-to-end development of medical devices and combination products from concept to formulate transfer for efficient lifecycle.
• Developed technology and manufacturing process of cutting-edge Smart connect drug delivery device and software as a medical device (SaMD) products to enable remote patient monitoring and improved patient experience..
• Developed high volume commercial manufacturing processes with contract manufacturer of Class III ocular implantable drug delivery program, leading a cross functional packaging workstream and a process engineering team.

• Collaborated with prominent medical device companies on international compliance and quality drives, leveraging engineering acumen to cultivate and maintain Class II and III medical devices, fortifying product quality.
• Spearhead a cross-functional team of 8 individuals in overhauling 600 design history files as per quality and regulatory benchmarks to improve compliance, processes, and efficiency
• Conduct detailed assessments of existing processes to identify compliance gaps and recommend improvements
• Deliver ongoing support and guidance to clients throughout product lifecycle, from development to post-market surveillance, while constantly training internal teams and stakeholders on compliance requirements and best.

Minneapolis, MN, US

• Developed and mentored ~14 direct reports encompassing manufacturing, electrical and R&D engineers as well as supply chain buyer/planners at 3 different locations with an annual operating plan of $4M
• Served as a key organizational resource by driving an offshore R&D design team in Hyderabad, India, and strategically resolving manufacturing issues, reverse engineering, and boosting operational excellence
• Conserved $1M by introducing a comprehensive business case and manufacturing transfer plan, enabling seamless production relocation offshore, and increased product availability and quality standards concurrently
• Spearheaded the program management of 60+ SKU technology transfer projects, collaborating with manufacturers across Germany, Bulgaria, Costa Rica, Malaysia, Puerto Rico, and Mexico for efficient transfer of technical.

Minneapolis, MN, US

• Oversaw all facets of product life cycle from process development, and budgeting to QA and post-market resolutions for 14 value streams and 325+ finished products in the Neurosurgery business unit
• Steered program management of 50+ projects, focusing on cost reduction, reverse engineering, design CAPAs, supplier transitions, device remediation, state-of-the-art compliance, and continuous improvements
• Recognized as a high potential contributor and selected to complete 6 month Medtronic High Potential Development Program

Minneapolis, MN, US

• Pioneered a department and developed a competent workforce of ~8 members encompassing manufacturing, electrical and R&D engineers as well as supply chain buyer/planners
• Managed Class II and III Finished Medical Devices at over 15 Contract Manufacturing/ OEM Suppliers and Medtronic Mexico.
• Minimized customer complaints by revamping legacy product designs at CMs/OEMs to optimize product availability and quality

Minneapolis, MN, US

• Revolutionized treatment of Hydrocephalus and seamlessly transferred Strata II Burr Hole valve and shunt from R&D to internal production by steering the manufacturing process development and launch of the product
• Onboarded and administered a dedicated remediation team of 5 employees for the corporate Medtronic Compliance and Regulatory Excellence (MCARE) project, focused on Process Validation and DHF remediation
• Launched two new MAPLAN injection molding machines developed for silicone molding while augmenting production capacity with an emphasis on enhancing product quality and consistency
• Increased operational efficiency by curtailing the need for manual operation of single cavity compression molds while slashing annual expense by $300K through the development of 12 cutting-edge multi-cavity molds

Abbott Park, Illinois, US

• Directed end-to-end product and process development of high-volume automated manufacturing equipment for commercial production of FreeStyle® glucose test strips, significantly optimizing production efficiency
• Infused novel technology into production procedure by administering capital equipment projects and, reducing operational costs while elevating the quality
• Amplified manufacturing yield by 20%, improved operational efficacy, and the accelerated process via the introduction of a new pressure-sensitive adhesive tape in close coordination with suppliers

Bagsværd, DK

• Supported commercial scale up of inhaled insulin combination device and dosage form product
• Improved equipment and processes for primary pharmaceutical packaging while working with external suppliers, resulting in qualification of new materials, and maintaining compliance with cGMPs and quality systems
• Steered GMP audits to assure QA and developed primary packaging materials specifications, decreasing non conformances and IQC testing needs
• Investigated manufacturing and quality issues through effective NCMR and CAPA management with suppliers

• Facilitated continuation of Phase 3 clinical trials by resolving critical design and manufacturing issues, as well as oversaw Dosage Form Development for pulmonary drug delivery of insulin and other liquid drug.

• Achieved remarkable improvement in commercial blister forming process, reducing blister ruptures by 10x, enhancing product quality and reliability

• Contributed to the development and characterization of aerosol drug products while optimizing manufacturing processes in close coordination with cross-functional teams, including scientists, engineers, management.

Bachelor Of Science - Bs, Biomedical Engineering

Education record

Honors Program

Certificate, Leading With A Global Mindset Program