Dave Malcolm Email & Phone Number

Parker, Colorado

StnDrd Infusion is a startup medical device company focused on developing a disruptive technology for the global infusion pump market. Our revolutionary infusion system simplifies and standardizes the market by combining the 3 types of general purpose pumps into 1 versatile, “smart” system. We combine 2 patented and tested design breakthroughs with “off the shelf” technology to deliver the clinical and safety performance for the most demanding clinical applications in the size, weight, and battery life for portability.

Project management, Medical device development, Electro-mechanical mechanism design, Process development, Process Automation

Englewood, Colorado

This contract is to assist the validation process during the development of a new medical device. The validation process includes: shipping and handling, design inputs to the product outputs, sterilization, IEC and FDA compliance.

Englewood, Co

Designed and implemented a new design for safe handling of oncology drugs. Comprised device development, device validation trials, resource management, managing junior engineers, and coordinating product transfer to production.

Lakewood, Co

Assisted FMEA analysis of Quantum tube set and associated accessory sets. Part of team developing and reviewing the disposable set FMEA. Finished development of the Quantum Barblock Crimper tool and developed IQ/OQ validations of clean room pneumatic assembly tool for high volume disposable production.

Englewood, Co

Assisted the transfer of manufacturing an infusion pump from Israel to Englewood, Colorado, including transferring component sourcing from Israel to US sources as appropriate. Set up the manufacturing system and performed validations of the infusion pump. Redesigned problem areas of the pump to improve manufacturability. Investigated design alternatives to accurately re-hydrate breath-testing device. Mathematically modeled several delivery systems, built prototypes, and tested potential methods. Performed failure-mode analysis to identify strengths and weaknesses. Developed implementation plan, including resources and expected costs. Presented concepts and associated testing results.

Parker, Co

Assisted in design of Platelet Gel device. Received patents on design of new centrifuge mechanism. Traveled weekly to Minneapolis for 18 months to implement device design. Wrote and performed design and qualification tests. Assisted with the implementation of electrical, software, and quality systems and designs. Traveled to Switzerland to meet with design staff on system requirements for transfer of centrifuge device to U.S. Developed multi-national equipment manufacturing process and process control systems. Member of team designing assembly process and controls for clean room manufacturing of disposable tube sets. Investigated system and tube set problems regarding their interactions. Collaborated successfully with molding and blow molding vendors to resolve component issues. Developed manufacturing tooling for tube set manufacturer. Specified qualification protocols and performed qualification testing.

Bsme, Mechanical Engineering

2Nd Degree Black Belt, Taekwondo