Director/Senior Director of Product Development
Menlo Park, CA
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 aseptically 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 commercialization
- 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
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