Description
Abiomed is recruiting for an NPI Operations Manager, located in Danvers, MA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .
Key Responsibilities:

• Lead global multi-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 feasibility, qualification builds and through commercial production ensuring operations predictability.
• Build manufacturing strategies with guidance from collaborators to ensure planned completion in line with phase gate reviews.
• Partner with research and development to ensure DFM during early stage of product development.
• Manage all operations related communication through organization by bringing visibility on key issues with an adequate business solution to the executive team.
• Find opportunities for design and process improvements and drive implementation to ensure business continuity.
• Influence design specifications and processes to achieve the best quality and optimized for cost, manufacturability, supply chain flexibility and operational efficiency.
• Communicate project status, schedule progress and key project metrics through standardized processes for program management.
• Plan and coordinate implementation with global multi-functional teams and traveling between facilities.
• Support and enforce company goals and objectives, policies, and procedures, GMP, GDP, FDA QSR, and ISO regulations.

Qualifications

• Bachelor's or master's 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 operations with capability of prioritizing multiple projects in parallel.
• Strong interpersonal skills and with ability to work with engineers and all level of management
• Experience with statistics, statistical tools/techniques.

Preferred:

• LEAN Manufacturing certification and proven track record of implementation
• Experience developing products under FDA control
• Six Sigma Green Belt (Black Belt preferred) certification

Other:

• Excellent verbal and written communication skills.
• Willingness to travel internationally up to 25% to support position's responsibilities.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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