Meet Luke

Position Summary: Mr. Beery supported the development and maintenance of firmware requirements and system‑level verification for multi‑node platforms, including preparation of firmware documentation for FDA 510(k) submission. He also served as Product Owner for an Agile Scrum team, guiding firmware engineers and product development efforts through organizational change.

Mr. Beery supported the development and commercialization of lower limb prosthetic devices. He worked as the product manager of the prosthetic foot portfolio, developing roadmaps and business cases for prosthetic feet, leading cross functional efforts for commercialization, and post launch monitoring. Additionally, he supported transfer of foot manufacturing activities moved out of headquarters to another company out of state. As a project engineer, Mr. Beery supported the development of a manufacturing process to produce a prosthetic liner to cool a patients’ limb while in use and led the development efforts from concept to manufacturing of a mechanical vacuum pump.

Mechanical Vacuum Pump: Mr. Beery led the development of a mechanical vacuum pump for use in a lower limb prosthesis. The pump draws a vacuum on a patient’s residual limb with each step. Several design paths were pursued, and iterative prototypes were rapidly fabricated to evaluate which best met the user and stakeholder needs. Mr. Beery collected customer insights by observing customers use of prototypes in clinics to incorporate features to improve usability and user experience. Changes to prototypes were evaluated frequently with end users to document and incorporate feedback. Mr. Beery then led the development of the chosen design path to meet rigorous testing standards, including ISO 10328 and ISO 22675, and developed manufacturing processes. He also developed a method to mechanically control a “high” and “low” vacuum setting.

Hydraulic Ankle: Mr. Beery led the development of a prototype prosthetic hydraulic ankle for use in a lower limb prosthesis. He built a multi-year project schedule and managed the establishment and assignment of engineering tasks for the New Product Development team. He led the group with 1-2 week development sprints to develop the proofs of concept, test protocol generation, and feasibility prototype design before resources were reallocated to a higher priority opportunity.

SmartTemp Gel Liner: Mr. Beery contributed to the development of a prosthetic liner that delays the onset of sweat from an amputee’s residual limb within their socket. His involvement ranged from solving user needs, to manufacturing process refinement, to facilitating cross departmental communication.

Product Management of Prosthetic foot portfolio: Mr. Beery conducted product line assessments and created end of life plans for aging product lines. He also combined market data, customer insights, and technological breakthroughs to develop a 5-year road map of prosthetic foot products to complete the prosthetic foot portfolio with state of the art solutions. He managed the successful commercial launch of the first two products in that portfolio, coordinating efforts of engineering, manufacturing, sales, marketing, education, and IT. He also generated requirements documents for subsequent product releases based on customer insights and business needs. Additionally, Mr. Beery served as a liaison with the contract manufacturer of foot products, prioritizing and strategizing the production of backlogged customer orders.

Position Summary: Mr. Beery supported the development of MRI coils for use with multiple OEM MRI systems. He gathered user and stakeholder needs, designed and built prototypes, conducted verification and validation testing, supported manufacturing design transfer, IFU compilation, DHF generation, and conducted hazard and risk analyses throughout development in compliance with 21 CFR 820. Specific product platforms include:

GE/Siemens/Canon Medical Knee Coil: Mr. Beery designed the mechanical housings knee coils to enclose electrical components and accommodate patient anatomy to improve patient positioning and throughput in the MRI suite. This involved the integration of design requirements for a common platform to be used across multiple OEM customer systems and electrical configurations to decrease design variability across product lines. In addition to design and procurement of parts, he participated in verification and validation activities, developing and executing lifetime durability testing to meet the customer needs. Customer needs were established and iterated through frequent evaluations of prototypes. He established a clear understanding of IEC 60601-1, ISO 13485, and 21 CFR 820 design controls in the process.

Knee/Foot Coil, GE Wrist Coil: Mr. Beery designed an alternate housing for use with the knee coil to accommodate foot imaging. He also contributed to the mechanical design of an MRI coil to capture high resolution wrist images. This included the development of a “slow close” clam shell design to meet ease of use requirements.

Position Description: Mr. Beery supported verification testing of updates to the portable oxygen concentrator products. Additionally, he participated in investigational designs of experiments to improve efficiencies of a novel oxygen concentrator design, working closely with the cofounder of Invacare. Investigational activities included evaluation of a Vacuum Pressure Swing Absorption (VPSA) system rather than the industry standard Pressure Swing Absorption (PSA) system, and optimization of nitrogen sieve design.

Position Description: Mr. Beery supported verification testing of next generation Implantable Cardioverter Defibrilator (ICD) by writing and conducting early risk reduction testing of the system to assist the team in finding bugs before formal verification work began. Mr. Beery also contributed to the design and development of the intranet site for Systems Engineers at Medtronic.