Upgrade existing systems related to sterilization, equipment validation, product shelf-life and transportation to ensure regulatory and quality compliance. Develop documentation to maintain updated systems. Add quality engineering principles to product drawing review system to reduce downstream errors.

Project management for development of new medical devices. Engineering and quality engineering management for equipment and process qualification. Development of design/process risk management files, master validation plan, device master records and associated design control documentation. Providing consultation for the translation of concepts to products by developing the “and” between research and development, development and process, process and manufacturing.

Project management for medical device company related to conversion of European regulatory requirements from Medical Device Directive to Medical Device Regulation.

Provide technical and leadership support in the development, evaluation, and manufacture of existing and new medical devices through the lifecycle of the products. • Oversee the technology transfer of new products into production, continuous improvement projects and quality initiatives for existing medical device and tissue products. • Provide mentoring and training to Operation management staff selected to manage new operations.• Direct and manage the workflow within the scope of assigned projects to ensure project plans adhere to agree upon timelines and budget. • Lead cross-functional teams to enhance the quality of products/processes, address design issues, and maintain existing product lines within Operations. • Serve a key member of the R&D Leadership Staff and be the subject matter expert for all technical and process engineering items. • Oversee team metrics and objectives that ensure business goals are met and surpassed. • Responsible for identifying, justifying and requisitioning new capital as required. • Develops high-level plans, schedules, resource assignments, and budgets for projects that reduces product cost and implement new products in the product portfolio. • Delegate and manage tasks among team members as appropriate to their skill level and risk to the project. • Works closely with peers in the Operations management, Marketing, Regulatory and Quality organizations to share best practices and processes, and to standardize communications and reporting to maintain a close working relationship to those outside the department. • As need assume responsibilities of Operations management or production management to produce materials for long term clinical studies and product introduction.

Manage the development and full transition of new technologies into operations.• Oversee the manufacturing technology transfer of new products into Operations continuous improvement projects and quality initiatives for existing medical device and tissue products. • Participate on cross-functional teams to enhance the quality of products/processes, address design issues, and maintain existing product lines within Operations. • Oversee team metrics and objectives that ensure business goals are met and surpassed. • Responsible for identifying, justifying and requisitioning new capital as required. • Delegate and manage tasks among team members as appropriate to their skill level and risk to the project. • Works closely with peers in the Operations and Quality organizations to share best practices and processes, and to standardize communications and reporting to maintain a close working relationship to those outside the department. • Assume role of Operations management or production manager to generate materials for clinical studies or initial inventory.

Manage the R&D side of the development and improvement of processes from bench R&D work to production.• Oversee the manufacturing technology transfer of new tissue-based products into Operations, • Direct and manage the workflow of engineers and subordinates. • Participate on cross-functional teams to enhance the quality and maintain existing product lines. • Oversee team to ensure business goals are met and surpassed.

Assay development, histology, photo-microscopy, documentation development

Biomechanical testing, animal tissue procurement, tissue characterization.