Christopher Edwards Email & Phone Number

- Create and update IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations, industry standards, and company requirements- Manage individual projects, representing the Instruction Design group, by coordinating with cross‐functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans- Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate- Maintain change history of instruction materials during their development- Produce low- and high-fidelity prototypes of IFUs, reference guides, and carton artwork for usability studies- Provide expertise and guidance to Human Factors engineering partners and other cross‐functional partners with content generation, illustrations, layout, and formatting of instruction materials- Manage junior staff and/or oversee external vendors to execute design work

Waltham, Massachusetts, United States

- Oversee the product design and creation (information architecture, usability, user interface design) for all SaaS tools and components within the B2B product portfolio of third-party management, optimization, and eCommerce site security- Provide product design input as well as wire frames and other prototypes to device development and engineering groups based on usability and user preference study results using Adobe Creative Suite (XD, Photoshop, Illustrator) and Figma- Establish standards and processes for project strategy and scope documentation, including usability testing and best practices- Conduct and oversee the staging of usability testing, card sorting, taxonomy exercises to various clients or focus groups. Analyzed and presented recommendations from the data collected- Ensure that corporate brand styles and guidelines are established and accommodated when designing web sites as well as community applications

Shirley, Massachusetts, United States

- Created a new division within the company for Human Factors Engineering and Product Design/UX- Set the strategic vision for Product Design/UX and HFE practices for multiple products (Mobile CT Scanners, Robotics, etc.) within the company using Adobe Creative Suite (XD, Photoshop, Illustrator) and Figma- Promoted design thinking at all levels of the company and demonstrated its ability to deliver business value.- Ensured that products and services provide the highest quality experience- Advocated for the customer in all decisions with the product, engineering, and design teams- Oversaw a team of UX and HFE research and design professionals- Ensured that product management and development teams received customer-focused UX/HFE guidance, services, and service levels- Developed, maintained, and continually improved processes for providing any/all research needed during feature/product ideation and prioritization including, but not limited to, user-centered design, continuous discovery, and the use of standard UX metrics- Ensured that research and design roles were adequately resourced for prioritized projects (both embedded initiatives and consulting initiatives)- Ensured that Product Design/UX and HFE staff delivered high-quality and timely research, design, and usability engineering services to product management and R&D efforts- Managed and reviewed research and design activities to meet project schedules with high quality and within budget.- Identified and hired resources/skills needed within the organization- Provided mentoring, performance management, and training of staff which included providing opportunities for training and education, and challenging UX and HFE staff to learn and apply skills and methods to help the organization achieve its goals

- Designed, developed, and implemented software (mobile applications and desktop) and web apps for a wide array of clients in multiple industries, including healthcare, finance and banking, and education.- Conducted human factors engineering studies to assess and test medical devices in accordance with regulatory usability and human factors requirements to ensure that our clients’ devices are safe and effective for users according to regulatory and industry standards.- Created a company that factors in the human element when solving clients’ business problems, helping design and develop products, environments, and technologies that are easier, safer, and more efficient for the people who use them.

- Created a new division within the company for Human Factors Engineering and User Experience Product Design, with a team of HFE, UI, IA, and developers to meet the needs of a Clinical Research Organization of over 10,000 employees worldwide- Designed protocols for various Human Factors medical device studies including auto-injectors, syringes, device labeling (packaging, inserts, training materials), etc. using Adobe Creative Suite (XD, Photoshop, Illustrator) and Figma- Facilitated the execution of Human Factors medical device studies by performing Task Analysis, Risk Analysis, and formative and validation testing- Managed multiple Human Factors medical device studies in both the US and Europe- Worked with clients to design and execute Human Factors documentation that adheres to FDA and AAMI guidelines including Failure Modes Effects Analysis (FMEA) documentation, Risk Analysis evaluation process/standards, user consent forms, Perception/Cognitive/Action (PCA) Task Analysis, etc. - Prepared Human Factors regulatory documents, such as HFE/UE Reports, for filing in both the US (FDA) and Europe (EMA)- Established Human Factors Quality Management standards and processes including standard operating procedures (SOP), work instructions, document templates, and checklists- Designed and developed applications that significantly shorten the time-to-market of late-phase drugs and the screening/recruiting/testing of both primary investigators (physicians) and patients conducting late-phase international clinical studies- Provided design input as well as wire frames and other prototypes to device development and engineering groups based on usability and user preference study results

- Managed team of UI designers and front-end developers to implement strategic processes to create private online communities for Communispace clients (e.g. Hallmark, Home Depot, Wells Fargo, Fidelity Investments, Best Buy, Mattel Toys, etc.). - Oversaw the design and creation (information architecture, usability, user interface design) for all external communities as well as internal applications, public sites, intranet, etc. Play specific role of UX consultant to all internal and external projects, working with each client to ensure that projects meet corporate approval, milestones, expectations, and budget.- Established standards and processes for project strategy and scope documentation, including usability testing and best practices.- Conducted and oversaw the staging of usability testing, card sorting, taxonomy exercises to various clients or focus groups. Analyzed and presented recommendations from the data collected.- Trained and managed team of designers, improving overall skill sets and advancing each employee’s capabilities.- Ensured that corporate brand styles and guidelines are established and accommodated when designing web sites as well as community applications.- Investigated and approved new applications, standards, processes, methodologies that can provide new offerings, directly impacting new sales and current client retention. - Oversaw resource allocation, schedules, budgets, and use of outside vendors including front-end developers, visual designers, copywriters, flash designers, etc. for all projects.

- Participated in the sales and strategy process to create online business communities for companies such as Deloitte, WebEx, PC Connections, VMWare, and Santa Fe Institute. - Oversaw the design and creation (information architecture, usability, user interface design) for all community tools andcomponents, such as blogs, wikis, discussion forums, prediction markets, social networks, and reporting tools.- Managed and designed all business collateral for the company, including rebranding of corporate identity, redesign of corporate site, redesign of all events collateral and brochures, etc.- Trained and managed team of designers, improving overall skill sets and advancing each employee’s capabilities.

- Worked with internal corporate companies such as Sonic Software, ObjectStore, and DataDirect to improve user experience (Information Architecture, Visual Design, Usability) for all print and online projects. - Oversaw usability and user experience for all corporate online/offline projects.- Implemented new processes for UX/IA capabilities within Progress Software to streamline efficiencies and save the company in external vendor expenses.- Trained and managed team of designers, improving overall skill sets and advancing each employee’s capabilities.- Oversaw resource allocation, schedules, budgets, and use of outside vendors for all projects.- Successful attainment of goal to save corporation $1,000,000 over two year period by retaining projects in-house instead of—prior to my employment—the exclusive use of outside vendors.

- Directed user experience professionals in developing highly successful solutions from concept and design through launch and completion for clients such as Chase/JP Morgan, Fleet Bank, Fifth Third Bank of Ohio, and Perkin Elmer.- Led and managed on-budget, on-specification, and on-time delivery of user experience solutions/projects for multiple clients including Chase/JP Morgan and Perkin Elmer. - Predicted and mitigated risk for user experience efforts. - Managed and directed team of user experience professionals (UX developers, visual designers, production). - Developed and enhanced client relationships at the senior/executive level for both PerkinElmer and Chase/JP Morgan. - Facilitated client work sessions at a senior/executive level. - Led proposal development and sales presentations.

- Co-founded and operated corporate web design and development company. - Responsible for business strategy; new business (with annual sales reaching $450K in revenues); staffing and management of eight employees; setting and meeting revenue goals; senior level client and project management. - Built employee-centric team environment conducive of strong creative thinking. Provided new ways to leverage fewer resources to achieve and exceed project goals including working with outside corporate partners and vendors to supplement capability sets and deliver on broader client needs. - Developed wide range of capabilities and products for two separate industries (corporate and educational) including extranets and intranets, e-commerce, site strategy and development, CRM, database architecture, user interface design, educational development tools, as well as interactive games and activities. - Structured deep, long-term relationships with General Mills, Fidelity Investments, State Street, Harcourt School Publishing, Scudder, Houghton Mifflin, Netegrity, Holt Rinehart and Winston. Project work for Mattel, Ziff Davis, and Pioneer Funds.

- Worked as a UX consultant with FeB’s Retail teams to redesign Fidelity Investments’ public retail site (6 months), including Fidelity’s Personal Home Page, universal navigation, and Private (post-login) Home Page. - Managed team of prototype designers and visual designers for the complete redesign of Fidelity’s ‘Personal Home Page’ site, bringing it to recent visual and usability standards.- Worked directly with FeB’s usability team to extract research and user data for the project, implementing basic and advanced online capabilities for the site.- Shared knowledge with other UX managers working on various projects with the public retail site to incorporate and ‘cross-sell’ other financial capabilities within the corporate sites.- Managed team of designers and developers to design Web sites, interactive media, 3D animation, and digital imaging to meet client marketing objectives in new and innovative ways. - Re-designed Fidelity.com interface and navigation during One Fidelity/Peter Lynch campaign. - Designed and developed newly created e-zine for Fidelity’s Focus magazine, which was the first online magazine utilize within Fidelity for potential (free) and paying (fee-based) customers. - Designed Fidelity’s Weekend Edition: Worked with strategic group to design and create a new Fidelity customer web site offering product and information for the ‘Weekend Investor’ within Fidelity’s existing high-value customers. - Created new interface and navigation for Fidelity’s Online Brokerage Trading System, Advisor Xpress, streamlining the usability and navigation as well as enhancing the look and feel of the application.