Katie Schindler

Medical Account Manager @ Mitsubishi Chemical Group

About

Medical device professional with two decades of experience transforming complex clinical needs into commercially successful products. I blend deep technical expertise with customer‑centric collaboration to help startups, universities, OEMs, and innovators accelerate development and navigate regulatory pathways with confidence.🔬 Professional Expertise 20+ years in medical device R&D, spanning concept → commercialization → post‑market support Expertise in implantable-grade polymers, antimicrobial combination devices, and advanced materials Proven track record leading global cross‑functional teams across full product lifecycles Contributor/reviewer for technical files, 510(k), IDE submissions, and responses to FDA & notified bodies Skilled presenter of technical data to FDA, surgeons, distributors, and commercial teams Co‑inventor on 3 issued patents | NAMSA biological safety certified | Six Sigma Green Belt🤝 How I Help Customers Simplify complex technical challenges with clear, actionable guidance Accelerate timelines with strategic material selection and early‑stage risk reduction Support startups, universities, incubators, and established device companies in research, development and building regulatory‑ready evidence Connect customers with the right resources to drive faster adoption, stronger performance, and successful market entryIf you’re working to bring an innovative medical device or material solution to market, I’m here to help you move faster, smarter, and with confidence.Connect with me on LinkedIn or email at katie.schindler@mcgc.comVisit our website: https://medical.m-chem.com

Country

United States

City

Fort Wayne

Industry

Medical Device

Skill

Six Sigma Green Belt, Project Management, New Product Implementations, Research, Orthopedics, Analytical Chemistry, Analytical Method Validation, Product Development, Product Launch, Team Leadership, Infection, Biomaterials, Medical Devices, R, Biomedical Engineering, Cross-functional Team Leadership, Design Control, FDA, ISO 13485, Leadership

Experience

Medical Account Manager

Mitsubishi Chemical Group

2025-8 - Present · 1 yr 2 mos

Responsible for Commercial activities for the Medical Market Growth Team targeted towards Start-Ups, Incubators and Universities to create awareness and adoption of MCG medical products in the Americas.

Senior R&D Scientist

Mitsubishi Chemical Group

2020-2 - 2025-8 · 5 yrs 7 mos

Responsible for project management and technical aspects of internal and customer-initiated new product development projects primarily related to medical grade UHMWPE. Customer facing interactions including preparing quotations for new projects, developing timelines, and reporting regular project progress. Work with current and new suppliers to increase capacity of critical processing needs. Process development and validation experience with custom blending, ram extrusion, direct compression molding, custom annealing, and crosslinking. Lead development and validation efforts for new test methods to advance laboratory efficiencies. Additional responsibilities include development and management of internal Healthcare Educational Series for multi-business unit commercial teams. Participation in multiple continuous improvement projects and completed Six Sigma Green Belt Training. Completed NAMSA course to become certified as a “Biological Safety Specialist.” Heartsaver First Aid CPR AED certified and serve on site PEO team.

Associate Director Of Development

Zimmer Biomet

2018-6 - 2020-2 · 1 yr 9 mos

Led a team of development engineers for the bone cement and accessories portfolio (base business and new product development).

Principal Research Scientist

Zimmer Biomet

2016-1 - 2018-6 · 2 yrs 6 mos

Warsaw, Indiana

Scientist and project manager for key development projects related to anti-infective technologies. Completed development and global market launch of 1 new-to-the-world technology. Provided sales training for new product launch. Managed global surgeon relationships for product development. Responsible for full product life cycle from design conception to post product launch. Led project and product testing efforts securing three 510(k) clearances for changes to existing products.

Research Scientist

Zimmer Biomet

2013-10 - 2016-1 · 2 yrs 4 mos

Warsaw, IN

Scientist and project manager for top development projects related antibiotic bone cement, cement spacer molds, and modern cementing technique. Led several projects with global cross-functional teams. Global market launch of 1 new-to-the-world technology. Responsible for design history files including project timelines, design inputs, design outputs and design transfer. Provided significant input to regulatory submissions and post market surveillance plans. Provided technical support and oversight for the analytical laboratory.

Research Engineer

Biomet

2010-6 - 2013-10 · 3 yrs 5 mos

Warsaw, IN

Engineer and project manager for development projects related to peri-prosthetic joint infection. Provided technical oversight of analytical test lab including software and method validations.

Analytical Chemist

Biomet

2006-6 - 2010-6 · 4 yrs 1 mo

Warsaw, IN

Responsible for developing and improving analytical laboratory capabilities to support development and quality assurance for major product lines. Also responsible for development of novel bone cement products related to peri-prosthetic joint infection.