Director/Senior Director of Product Development Corium International
The Director of Product Development will lead the design and development of drug-device combination microneedle products, including device development, drug processing, novel materials and processes development, and manufacturing process/equipment development, from proof of concept through clinical and commercial production. The position mentors and coaches an engineering group that designs, tests, integrates, documents and validates new product concepts/equipment, and new designs.
Responsible for Product and Process Development of asepticly manufactured Microneedle based drug delivery products
Provides senior leadership to Product Development engineers and contract manufacturers to develop and implement prototypes, prototype tooling, prototype and pilot manufacturing process, testing equipment, and testing/manufacturing procedures.
Lead teams in solving design or process problems (Champion six sigma and lean method development in the organization; facilitates problem solving techniques to overcome complex technical problems and provide solutions which are highly innovative
Develop models/systems to integrate and manage complex multi-discipline projects over the product life cycle
Responsible for leading technology transfer teams to pilot and/or commercial scale manufacturing
Interacts with internal and external management and customer representatives concerning projects, scheduling requirements and/or contractual clarifications.
Leads briefings and technical meetings for internal and external representatives.
Provide operational planning and budget development and management.
Supplier & consultant contract negotiation and vendor management.
Leads and manages the support for Operations group in failure investigation and product enhancement on existing products.
Create design control and CMC portions of regulatory submissions.
BS/MS/PhD in Mechanical Engineering or other related engineering discipline, with 15+ years of medical device and or combination product development experience in pharmaceutical/medical device industry; 10+ years experience in leadership role.
Successful experience with development and scale-up of medical devices and/or combination products from POC stage through commercilazation
Comprehensive product development design, design for manufacturability, industrial design, human factors, FMEA, and design control experience
Extensive experience in cGMP's and aseptic processing
Demonstrated proficiency with stage gate design control for device development and QbD for process development
Experienced in leading large scale projects and programs and direct supervision of advanced level engineers.
Experienced in regulatory requirements/submissions of drug-device combination products including design controls; familiar with CMC's requirements/submissions for the drug product
Experienced user of PC based design tools (design simulation, CAD - e.g. SolidWorks, AutoCAD, Mechanical Desktop).
Knowledge of cost effective design techniques.
Support of manufacturing to resolve production problems.
Excellent communication skills, both written and verbal. Ability to prepare technical reports and presentations to senior level management
Creation of schedules and budgets and tracking of tasks/budgets
||235 Constitution Drive |
Menlo Park, CA 94025