Christopher Johnson Email & Phone Number

San Diego, California, Us

• Led the completion and qualification of a suite of six single-cavity injection molds to produce the company’s assay product consumables for the launch of their first four CE Marked products for the EMEA market. Successes included root cause analysis and resolution of initial product defects during the molding process.• Led the development and qualification of the next generation of six multi-cavity, class 101 injection molds to support an increased product demand from the company’s three FDA 510(k) cleared assays, resulting in a 63% overall reduction in component costs. Achievements included component Design for Manufacturing/Automation (DFM) improvements to support future automated assembly.• Provided engineering support to successfully gain FDA 510(k) clearance for the company’s clinical diagnostics instrument.• Led a cross-functional team to design, build, test, and validate two lyophilized bead machines for both in-house manufacturing and in France. Completed a series of continuous product improvements resulted in a 65% reduction in bead costs and a manufacturing yield of 100%.• Technical lead for the implementation, process integration and validation of an in-house, 240 sq. ft. dry room facility capable of environmental control of products that contain lyophilized materials.• Led efforts to design, source, implement, and validate numerous pieces of manufacturing equipment, including two semi-automated vial capping machines, two semi-automated pouch sealers, an automated pouch labeling machine, and several manual jigs and fixtures, reducing manufacturing cost by 18% over the course of 14 months.

Franklin Lakes, New Jersey, Us

• Program Manager of the business unit’s number 1 global priority to consolidate more than 5,000 SKUs across 5 manufacturing plants worldwide to become a harmonized, best-in-class product portfolio.• Program collaborates with more than 12 concurrent development projects, 9 other corporate programs, and numerous Sustaining Engineering initiatives.

Neuilly-Sur-Seine, Fr

• Project/Program Manager and Core Team Lead in an ISO 9001/13485 contract new product development company for development of Class II and Class III medical devices.• As part of a Matrix Organization of international, multi-disciplinary talent, led, coached and mentored teams that included mechanical, electrical, software, optical, quality, and test engineers on projects that lasted from 6-24 months and generated as much as $2.5M in revenue.• In addition to PM responsibilities, functioned as Subject Matter Expert (SME) for $50k – $150k consulting engagements for clients in the biotech space. SME roles included design, manufacturing (methods, materials, DFM, and DFS) and new product pipeline strategies and planning activities.• Collaborated with Altran’s New Business Development team to interface directly with current and prospective clients to develop business proposals for contracts up to $3.7M.• Participated as part of the company’s technical staffing team to identify the necessary disciplines for new engagements, assessed team skills gaps, and developed remediation and training plans for those gaps.• Provided both Technical and Programmatic Leadership to develop project budgets and timelines, drove new product development progress, and managed staffing plans, ensuring compliance with corporate and FDA new product development and release requirements.• Communicated directly with both client and Altran senior management to provide written and oral status of project milestones, budgets, timelines, risks, and risk mitigations.

Neuilly-Sur-Seine, Fr

Foliage was acquired by Altran. Please see Altran experience above.

San Diego, California, Us

• Recruited into this startup company to provide hands-on Strategic and Cross-functional Management of a $6.2M next generation diagnostic instrument program that included a silicon photonics-based reader and biosensor, embedded software, and custom consumables.• Formulated and drove comprehensive departmental and project budgets that included FTEs, third-party consulting, capital equipment acquisitions, facilities, and new product development expenses.• Built mentored and coached a team of mechanical, electrical and software engineers from the ground up to form a lean, efficient development team commensurate with that of a bootstrap corporate budget.• Architected the New Product Development Procedure to integrate both the Instrument and Assay development efforts into a single, harmonized system that addressed the new product pipeline, project reporting, commercialization materials, and customer feedback.• Instituted and drafted the company’s Manufacturing, Material Requirements Planning (MRP) and Quality Systems processes and procedures, then aided in hiring the requisite personnel to grow those departments.• Implemented an 8-Step Problem Solving Process to efficiently identify and resolve product issues using a minimum of scarce company resources.

• R&D department engineering manager of cross-functional technical disciplines for the development of next-generation products. Supervised a team of 10 including mechanical, electrical, system, and software engineers and designers.• Core Team Lead for a $4.2M Class II light transmittance-based instrument development program that included the internal R&D team working together with multiple contract engineering companies. Development efforts ranged from initial industrial design concepts and user interface storyboards to the final instrument that included production-quality injection molds; embedded, real-time software; database design for the instrument client app; and transfer to a contract manufacturer.• Drove efforts to integrate design for reliability and design for manufacturability into the early phases of product development in order to facilitate an efficient and seamless transition from R&D to Manufacturing.• Managed and Designed upgrades to current line of disposables and ensured that those changes were compatible with and incorporated into the existing $1.5M automated assembly table.• Coordinated sustaining engineering efforts to evaluate technical and manufacturing issues for the existing product line in order to maintain corporate production and revenue goals.

• Led a team of 3 to collaborate with in-house multi-disciplinary departments and third party vendors to develop the disposable portion of a lateral flow assay designed for use with a fluorescence reader for the POC environment. Third party vendor management included injection molding, specimen collection device manufacturing, contract filling and packaging, contract engineering, and industrial design services.• Project leader for the Verification and Validation (V&V) efforts to support an FDA 510(k) Class II submission of the company’s NC400 diagnostic platform capable analyzing multiple DNA and RNA targets. Functions included devising technical solutions to challenging manufacturing issues in support of post launch continuous product improvement activities.• Oversaw the instrumentation V&V efforts for an FDA 510(k) Class II submission of the i-Lynx reader designed to work with a lateral flow assay device for detection of cardiovascular and infectious diseases.

Us

• Managed multiple projects to design, fabricate, validate, and implement an array of test and manufacturing equipment in support of the Intraocular Lens Insertion Systems.• Project leader of an interdisciplinary team formed to design and fabricate an automated cartridge coating machine. Project leadership included system architecture design, coordination of interdepartmental and third party engineering resources, budgeting, and design reviews. Machine was delivered on schedule and within budget, and exceeded throughput requirements by 60%.• Project leader for the development of an automated, real-time data acquisition system. Data was used to characterize insertion systems while improving the inserter-physician interaction.

• Designed the structural support, mechanical packaging and manufacturability of nuclear radiation shielding for the company’s new line of 22 Cross Belt Bulk Material Analyzers.

Carlsbad, California, Us

• Project leader of an interdisciplinary team of mechanical, electrical and applications engineers to design a creative and robust missing part detection system.• Lead an 8-Step Problem Solving project to address a tactile height sensor failure. The project resulted in identification and resolution of the offending failure mode and prevented a 250% increase in manufacturing costs.• Provided product engineering support of the Surface Mount Adhesive Dispenser platform production line.

• Designed and tested electromechanical and pneumatic assemblies in support of the company's automated pick and place computer chip test handlers.• Reworked and automated the design of computer chip tray inserts using parametric solid modeling that reduced design time from 3 days to 2-3 hours, as well as added finite element analysis (FEA) capabilities for design verification prior to purchasing expensive tooling.

• Designed and reviewed tooling, fixtures and machining centers that related to actuator manufacturing. Concurrently, designed, specified and integrated equipment to automate the company's polyurethane extrusion equipment.

RJ Environmental, Inc. was a privately held company. It is now a division of Siemens Water Technologies.• Designed all aspects of the scrubber system, including mechanical and electrical control panel design, and liquid pump and pressure blower sizing and integration. Managed over $1M in as many as 10 concurrent projects. Designed fiberglass reaction chambers, sheet metal, and welded skid systems, wrote Operations and Maintenance manuals and performed installation and training functions at the customers' facilities.

Bs, Mechanical Engineering

Project Management Essentials

Designed Experiments (Doe)