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..
• 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%.
• 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%.
• 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.

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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• 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..

Bs, Mechanical Engineering

Project Management Essentials

Designed Experiments (Doe)