Management of Business Unit Manuals and Labeling Projects                                       
Coordinated the development of all labeling and manuals required for a wide range of heart valve product lines. Projects required extensive interaction and problem solving with European colleagues, and those within engineering, regulatory, and documentation groups.

  Manual Development: Software-Driven Cardiac Surgery Ablation Instrument          
Managed the development of user manuals for software driven cardiac surgery ablation instrument. Worked with the development team to write manuals and labeling that fulfilled clinical and legal requirements, US FDA and European Community (CE) regulatory requirements, and corporate communication standards.

  In-Line Surgical Leads, Low-Profile Extension Project          
Supported the medical product development team as sole Technical Writer responsible for implementing multiple product manuals and product labeling to accommodate new implantable neurological devices. Project work included attendance in regular, on-site team meetings, assisting in clinical tests documentation, management of manual review processes, working with European co-workers, and the completion of European manuals and labeling.

   Manual Development: Hypertension Diagnostic Device                                                        
Conceptualized, wrote, designed, and completed 100+ page manual for medical device programmer. Manual contained extensive screen captures, step-by-step user instructions, device set up, patient applications, clinician troubleshooting, and detailed tables of contents, indices, and appendices.