NPI Operations Manager
The NPI Operations Managers will manage the new product development by collaborating with R&D and coordinating all the efforts by operations to successfully introduce into production. They will oversee the transition of new products and approaches into production by pushing design for manufacturability early in the design phase and pulling product into production when the design is complete.
Principle Duties and Responsibilities:
Lead global cross-functional team in planning and coordinating development and production transfer efforts through recurrence meeting and travel between facilities.
Lead the operations team and collaborate with the development team from V&V builds through commercial production ensuring operations predictability.
Create manufacturing strategies with input from stakeholders to ensure timely completion in line with phase gate reviews.
Partner with research and development to ensure design for manufacturability (DFM) during early stage of product development.
Manage all operations related communication through organization by bring transparency on key issues with an adequate business solution to the executive team.
Identify opportunities for design and process improvements and drive implementation to ensure business continuity.
Influence design specifications and processes to achieve best quality and optimized for cost, manufacturability, supply chain flexibility and operational efficiency.
Communicate project status, schedule progress and key project metrics through standardized best practices for program management.
Plan and coordinate production transfer efforts with global cross-functional teams and traveling between facilities.
Support and enforce company goals and objectives, policies, and procedures, GMP, GDP, FDA QSR and ISO regulations.
Bachelors or Masters Degree in Engineering or Technical field.
8+ years of relevant work experience with strong program management skills (medical device experience preferred).
Experience in bringing new products from R&D to production with capability of handling multiple projects in parallel.
Strong interpersonal skills and with demonstrated ability to work with engineers and all level of management.
Excellent verbal and written communication skills.
Experience with statistics, statistical tools/techniques.
Willingness to travel internationally up to 25% to support position’s responsibilities.
LEAN Manufacturing certification and proven track record of implementation.
Six Sigma Green Belt (Black Belt preferred) certification.
Experience developing products under FDA control.
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