Robert Minderman Email & Phone Number

Cincinnati Metropolitan Area

Cincinnati Metropolitan Area

-Lead a cross functional team to develop a novel large volume injector in partnership with a pharmaceutical client-Responsible for the program management plan, including strategic plans for quality, regulatory, HF, and design control-Manage client relationship working through issues such as CE marking, sterility assurance, and statistical.

Indianapolis, Indiana Area

-Provide support to molecule projects in the Diabetes and Immunology portfolio from pre- Candidate Selection to End of Phase 2, including development of plans, timelines, information management, and regular program updates-Control budget and schedules for a dynamic Phase 2 immunology project, with a development partner, undertaking 4 clinical trial.

Indianapolis, Indiana Area

As a member of the Lilly Delivery, Device and Connected Solutions' Systems Engineering organization:-Acted in a dual role of Project Manager and Systems Engineer for a novel software and hardware, currently under development-Developed User Needs, and System Requirements, necessitating the execution of a Standards and Regulations check, for a novel device

Indianapolis, Indiana Area

-Directed creation of Early Feasibility Clinical Trial Development Plan for delivery device with embedded software, including many risk-based, company-first deliverables, such as a device evaluation strategy per FDA guidance-Documented test plans and testing results executed by internal and external testing groups for reusable needle-based injection device.

Indianapolis, Indiana Area

- Managed workload and performance of 5 engineers at customer site while maintaining my own client projects- Embedded as Process Mechanical Lead for single-use pharmaceutical delivery device assembly equipment - Developed User Requirements for medical device assembly equipment to follow client and industry standards- Partnered with client’s associates to.

Indianapolis, Indiana Area

Client: Eli Lilly and Company, Indianapolis, USADrug Delivery Device Commercialization / Manufacturing Group- Traveled internationally to supervise and guide fabrication, commissioning, and qualification of medical device assembly equipment- Delivered business critical assessments, reports, and studies while embedded in supplier's German site.- Developed.

Greater New York City Area

Led manufacturing engineering efforts to increase production 400% in 1.5 years with minimal headcount increase.Initiated company-wide equipment and process validation and documentation program in-line with ISO standards.Performed Installation and Operations Qualifications on production automation to reduce risk and assure quality.Developed novel packaging.

Indianapolis, Indiana Area

-Developed and implemented program to reduce cost of goods by $342,000 annually.-Utilized statistical methods to develop automation best practices in a packaging environment.-Participated as founding member of employee continuous improvement team, saving $30k in the first six months.-Managed project to transform packaging department’s work techniques and.

Indianapolis, Indiana Area

Implemented ergonomic corrective actions to reduce injury risk in clean room environment.Prepared specifications, negotiated with vendors, and performed analysis for machinery with $60,000 budget. Performed project leader duties to resolve high-value customer complaints on high volume product line.Executed time and motion studies to aid development of.

Columbus, Ohio Area

-Participated in process change activities, including trial support, fixture design, approvals, and process support.-Created standards for line-side delivery of specialized containers of assembly components.-Collected, archived, and analyzed data for inter-departmental project to improve supply chain efficiency.-Developed design documents requiring input.