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Working at Corium
Director/Senior Director of Product Development
Menlo Park, CA

Major Responsibilities

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.

Position Requirements

  • 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

Please e-mail your resume to menloparkjobs@coriumtech.com

 

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