Robert Allen Email & Phone Number

Illinois, United States

Buffalo Grove, Il

 Lead the design transfer activities from European design site and identify design & manufacturing risks  Develop project plans in excess of $20 million for the industrialization of combination devices Responsible for maintaining project budget, limit financial exposure, and ensure profitability  Support and facilitate design of experiments device testing Organize and implement stability batch assembly and testing Support and determine the impact of device critical parameters on production Implement companywide initiative of handling controlled substances and serialization within the site Organize and advise cross functional management team to develop processes, cleanroom buildout, and compliant security measures for site readiness Identify and hire key personnel, subject matter experts, quality, and regulatory consultants to ensure project success  Managed a quality documentation system compliant with FDA regulatory requirements for handling drug product  Manage the validation activities of combination devices for injection molds and high-volume assembly equipment Construct detailed project timelines to drive short and long-term priorities to deliver the project on time Manage customer expectations and resolve conflict to build trust Implement track & trace serialization controls compliant with the Drug Supply Security Act Communicate complex technologies to stakeholders and executive management through concise presentations Support quality personnel in the improvement of the new product development documentation to streamline audits Compose detailed technical quotes for new and out of scope customer requests

Elgin, Il

 Managed and motivated a group of program managers, embedded software/hardware, and mechanical engineers in the design and development of Class III medical devices from initial concept to production Determined multi-project team assignments and schedules to meet customer needs  Supported and cultivated customer relationships for new and repeat business Created and presented detailed customer presentations on product lifecycle and standards Determined development costs and provided detailed technical quotes for start-ups and established businesses ranging from $300K to $4M Developed and implemented new product development design control procedures compliant with the Medical Device Directive, 21CFR820, ISO 13485, ISO 14971, and IEC 62304 standards Directed embedded software & hardware engineers to develop architecture compliant to IEC 62304 Implemented Agile-based management system and lean methodologies improving product lifecycle timelines Managed and oversaw design of experiments device testing and external lab testing to 60601 standards to support essential performance Supported design control audits by the FDA, registrars, and customers without major findings Interviewed and hired full-time and temporary engineering staff to meet project timelines and goals Identified and managed outsourcing of software, industrial design, circuit board layout, FEA, and tooling both domestically and in South Asia reducing the impact on overhead Recommended engineering equipment and software tools to executive management team for continuous improvements  Set key performance indicators for program managers and engineers improving development activities Trained and supported sales and marketing staff on product lifecycle and regulatory standards

Elgin, Il

 Led a group of embedded software/hardware, and mechanical engineers in the development of class III medical devices including: epidural injection system, insulin pump, pupilometer, and other devices Guided and mentored the engineering team through product life cycle, software & hardware architecture, and regulatory standards Maintained the development deliverable schedules and met device costs Wrote development plans and guided the team on the creation of required output documentation Held and documented phased based NPD design review approval meetings with customers Managed the impact of out-of-scope tasks and provided detailed quotes to customers Supported the manufacturing group in process verification and production software validation Provided customers with risk management support and guidance Oversaw the hardware design to meet independent lab testing to IEC 60601-1 for Basic Safety, IEC 60601-1-8 for Alarms, IEC 60601-1-2 for EMC, and other device-specific standards

Elgin, Il

 Mechanically designed the following instrumentation using experience in plastic injection molding, thermal formed plastics, extrusions, blow molding, die cast, sheet metal, and machined parts;o Human Liver Transporter- Class II medical device designed to medical industry standardso Epidural Injection and Intra-Articular Injection systems – Class III medical devices designed to medical industry standardso Video Spectrophotometer System – designed to industrial equipment standardso Ram Air Turbine Stow Panel Module for 747-8 aircraft – designed to DO160E airborne equipment standard

Crystal Lake, Il

Program management and electromechanical design services. Mechanical design of electrical power station amplifier for the electrical vehicle industryElectromechanically designed a consumer grade portable wireless cell phone amplifierDesigned a universal alarm device using PADS PCB and SolidWorks software

La Fox, Il

Program Manager / Senior Mechanical Design EngineerProgram manager of RF, Electrical, and Mechanical Engineering group for the design and development of cellular base station amplifiersProvided initial quotes and out-of-scope quote to customersBuilt solid relationships with key suppliersHands-on involvement in all aspects of electromechanical design using industry leading software Electromechanically designed low cost, easy to manufacture products including: o Low power bi-directional automotive repeaters – volume of 600K o 100 to 300 watt power amplifiers from 900 MHz to 1800 MHz o Medical amplifiers o Cellular jammers o Remote control interfacesThermally analyzed amplifier designs using software models and correlated physical prototypes using thermal camera and other test equipmentDeveloped and implemented an engineering design documentation system to comply with QS9000 quality standardDesigned plastic injection, zinc and aluminum die cast parts for high volume productionCreated mechanical prototypes using EdgeCAM software for CNC vertical mill

Hoffman Estates, Il

Engineering Manager / Co-founder (sold to Richardson Electronics in June of 1998) Engineering Manager of RF, Electrical, and Mechanical Engineers in the design and development of high power cellular base station amplifiers Primary lead electromechanical design engineer for all products

Mechanical Engineering

Associates, Science