Scott Cameron Email & Phone Number

El Granada, Ca, Us

San Francisco, Ca, Us

Lead the design, development and implementation of drug device combination products. Implement the required regional regulatory processes for design controls, risk management and product realization. In addition, support our contract manufacturing organizations for timely delivery these products as required to meet business milestones in pre and post market.

SRC Designs & Associates offers consulting services that enables US and EU market access for medical devices and drug/device combination product manufactures. We provide the bridge from quality data to build regulatory submission document packages. Leveraging our extensive experience in these fields, we facilitate this process efficiently while highlighting and minimizing business risk for our clients.Our methodology is to leveraging regional health authority regulations, guidance and recognized industry consensus standards for the US and EU to generate high quality GMP documentation deliverables that are summarized and attached into the submission framework. This process builds robust submission content for health authority review and consideration. We also offer to review clients Quality Management System to ensure it is able to produce the required regional document deliverables. We are able to counsel our clients from a compliance and market access submission perspective that is efficient, and value added for their organizations.Areas of Focus:Regulatory Strategy Program ManagementQuality Management Systems Design Controls and Product Realization Design Verification and Validation Human Factors Risk ManagementProduct specifications

San Rafael, Ca, Us

• Quality Assurance leader directing product lifecycle management activities in device design, development and quality systems implementation. Functional lead on regulatory requirements, risk management, design controls, change control, DHF management and compliance for multiple projects in our combination product portfolio.• Quality system gap assessment and implementation planning to meet FDA and EMA regulatory requirements.• Successful development and commercialization of Voxzogo drug/device combination product for the treatment of achondroplasia.• Effective leader in post market manufacturing and sustaining operations for product lifecycle management across the drug device combination product portfolio.• Lead and define the pre and post market product design and development lifecycle processes per regulatory requirements in the US and EU.• Provide quality oversite for all Human Factors studies for multiple combination products.

South San Francisco, California, Us

• Medical device consultant with Genentech on device development activities that included: Project planning, capital test equipment qualification, compatibility, stability testing, design control, risk management and process engineering on combination product medical devices. SME reviewer of critical to function and safety attributes defined in specifications for devices and capitol equipment in development.

New Brunswick, Nj, Us

• Responsible for supporting the manufacturing of the Johnson and Johnson One Touch Via insulin delivery device for use in their post market clinical trial.• Focus on product quality, external component fabrication processes, internal assembly processes, design controls, risk management and quality system.• Cross functionally I interfaced with manufacturing engineering to facilitate process development and R&D to facilitate specification refinement utilizing data driven methods.• Managed a group of quality engineers who supports IQC, supplier quality, component specifications, quality system improvements, manufacturing processes and final product quality. Hosted weekly MRB meetings with engineers, present monthly to management.• Regularly presented to upper management for visibility on component supply, control chart trending, supplier quality, NC status, and CAPA status and production process yield.• Write protocols, work instructions, SOP’s, develop samples plans, review and update FEMA’s, perform statistical analysis on control data.• Drive root cause analysis projects and provide regular updates to the team.• Inspection and Test method development, validation and statistical process control.• Manufacturing process development, validation and statical process control.• Training matrix development and management.• Production bath record review and process trending using statistical techniques.

• Pulsar had a class III implant platform for treatment of intracranial aneurysms.• Pre-clinical program management for technical development.• Implementation of Finite Element Analysis to facilitate rapid technical development.• Achieved successful animal model design implementation that led to first in man.• Achieved successful design verification and validation in human use. • SME reviewer and approver of all design and product specifications.• Oversite of ISO 13485 Quality Management System implementation and certification.• Organize and direct the activities in device design, verification, validation, manufacturing process development and quality.• Technically lead in the design and manufacturing process development, master validation plan and validation protocols of critical processes.• Proprietary manufacturing processes for custom component fabrication and assembly.• Key contributions were providing technical guidance to achieve product specifications, manufacturing process development and validation, quality system implementation and management, supplier quality management and inspection method development.• Successfully completed key business milestones e.g. CE Mark, ISO 13485 certification and FDA IDE approval on their initial commercial product platform.

Sunnyvale, Ca, Us

• Managed the mechanical engineering group which designed and developed their complex hand-held insulin pump device from concept through to FDA 510k filing.• Selected and managed all custom fabricated part suppliers and associated tooling.• Reduced plastic injection molding prototype and market entry tooling budget from $1.5 million to $400K.• Provided critical technical leadership that lead to numerous solutions ultimately enabling a successful V&V completion for the microprocessor electromechanical device.• Worked cross functionally to develop product specifications and mitigate risk.• Implemented design solutions that facilitated manufacturability of components and assembly of the system.• 33 Plastic injection molding tools were brought on-line to accomplish our objectives within an accelerated schedule.• The FDA granted approval Q2 2011 on their 2-part disposable – durable self-injection device.

• Responsibilities were to improved manufacturability of the Rennessa® disposable ablation catheter probe, which had passed FDA approval in late 2005.• All manufacturing process changes were completed without impacting the product specifications.• Key contributions were my hands-on redesign to the catheter anchoring balloon and characterization of the Nitinol (NiTi) needle array.• Solved a number of labor-intensive manufacturing process issues which substantially improved yields, reduced cost and improved product quality by up to 75%.• Implemented improvements to quality inspection processes to reduce inspection time.• E-Beam sterilization characterization and validation working with supplier.• Managed a staff of 5 in house including our machine shop and all of our contract manufacturing facilities located around the country.

• Product development team member of needle-free drug delivery devices, taking the product from the design concept stage and continue through commercial part and assembly design.• Responsible for product lines; Intraject (now Zogenix DosePro) needle free disposable aqueous subcutaneous pre-filled injection system and AERx electromechanical, microprocessor-controlled hand-held pulmonary drug delivery systems.• Received an award for innovation utilizing cutting edge technologies for solving real world design problems.• Presented my next generation concepts to Novo Nordisk in Denmark who chose my device designs for development that led to the expansion of our license agreement.• Created the industrial design, plastic injection molded part design and semi-automated assembly machine design for the Intraject device.