Sr. Mgr, Process Development, IE

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 https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Multi-Family R&D Operations

Job Category:

People Leader

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Senior Manager, Process Development, Innovation Exellence. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Senior Manager, Process Development, Innovation Excellence is responsible for leading and playing pivotal enabling role towards process development and optimization that drives innovation and scalability of all commercial Impella pump products in collaboration with cross-functional teams. The role focuses on providing technical expertise, developing global standards and best practices, and building capability to enhance manufacturing performance, product quality, and compliance. The ideal candidate is a strategic thinker and a results-driven leader who thrives in complex environments combining deep process expertise and balancing creativity with analytical rigor to deliver measurable business outcomes.

 

Process Innovation & Continuous Improvement

• Lead initiatives that focus on process optimization and continuous improvement to enhance operational efficiency of commercial products.

• Responsible for process development and characterization in multi-functional lifecycle and critical sustaining projects (Scaleup, Automation, Yield, Obsolescence and 2nd source)

• Process subject matter expert support for internal technology transfer, installed capacity improvement, product development and process characterization of initiatives new initiatives.

• Work collaboratively with Product Engineering, Manufacturing, and Quality to identify and implement process solutions that enhance product performance and manufacturability.

• Serve as a subject matter expert in process development, advising teams on risk assessment, design-for-manufacturability and regulatory implications.

 

Sustaining, Quality and Compliance

• Process subject matter expert support for Production Engineering on non-standard production work, failure investigations and containment challenges.

• Act as second line of defense to support production on non-conformance escalations and complex failure investigations.

• Contribute to the development of standards, best practices, and technical documentation to ensure consistency and compliance across manufacturing locations.

• Responsible for process specific corrective actions in manufacturing area due to escalations, post-market surveillance complaints.

• Responsible for driving and support process specific CAPAs, DRAs and Internal Audit Observations ensuring compliance to meet QMS requirements.