Sr. Manager , NPI

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

The New Product Introduction (NPI) Manager will play a key role in expanding NPI activities including assisting in the development of a pilot manufacturing facility, and guiding the development of new manufacturing processes. The NPI team is responsible for the successful transfer of products and processes from development to production within GMP & ISO regulations.

 

  • Manage, grow, and provide leadership to direct reports.
  • Apply leadership skills to support, expand and reinforce the role of the NPI team within the organization.
  • Facilitate communication and cooperation between Development teams and Manufacturing Engineering.
  • Drive validation activities related to the production of new molecular IVD products, as well as the processes, test methods and manufacturing equipment required for the production of those products.
  • Play a key role in guiding product development toward manufacturability from early in the design process by participating as a member of the Product Core Team and being a key point-of-contact representing Technical Operations.
  • Lead multiple small and large projects simultaneously.
  • Respond to external and internal Audits.
  • Effectively liaise with other areas of the organization including Marketing, Regulatory, Quality, Manufacturing Engineering and Development representatives to ensure successful and on-time product launches.
  • Provide technical leadership and technical know-how with respect to product requirements during the development of new manufacturing processes.
  • Effectively evaluate resource requirements tactically and strategically to support New Product Introduction and its expansion as appropriate.
  • Work together with S/W and electrical product transfer team to successfully transfer new products to production.
  • Project Manage product transfers from Sunnyvale to Contract Manufacturer.

 

 

Requirements
  • Minimum of 8 years experience designing commercial mechanical products.
  • Minimum of 5 years experience managing product development projects.
  • 3+ years as a manager of technical personnel in a fast paced environment.
  • Familiar with mechanical CAD software (Solid Works).
  • Knowledge of component manufacturing processes (including machining, injection molding, wire EDM, MIM electropolish, and heat treatment.
  • Detailed knowledge of Design Control processes.
  • Must have experience with validation/qualification
  • Working knowledge of GMP and ISO regulations
  • Excellent oral and written communication skills
  • Strong ability to author validation/qualification protocols and reports
  • Knowledge of the principles of validation across multiple disciplines, for example, process, equipment, facilities, and test methods
  • Working knowledge of experimental design and applicable statistical methods
  • Experience working in a manufacturing environment and/or within manufacturing operations
  • Ability to communicate technical issues both verbally and in written form
  • Effective organization and planning skills
  • BSME required
How to Apply

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