MANAGER, MANUFACTURING ENGINEERING NPI

Johnson & Johnson•Santa Clara, CA

1d•Onsite

About The Position

The NPI Manufacturing Engineering Manager will lead all New Product Introduction (NPI) activities required to develop, implement, and optimize manufacturing assembly processes for surgical robotics capital equipment. This role works closely with cross-functional teams—including R&D Hardware Design, Systems Engineering, Project Management, and Software—to support the full product lifecycle from concept through design transfer and production. The ideal candidate ensures that tools, processes, equipment, manufacturing instructions, and resources are in place to meet design and manufacturing requirements.

Requirements

Bachelor’s or Master’s degree in Engineering (Manufacturing, Industrial, Mechanical, Systems, Biomedical, or related field).
Minimum 5 years of experience leading technical teams in product or process development, with emphasis on mechanical assembly in Automotive, Medical, Capital, or Industrial equipment.
Experience working with Contract Manufacturers and global supply chains.
Proficiency in SolidWorks CAD and mechanical design.
Lean Six Sigma training with strong root cause analysis and continuous improvement skills.
Experience with metrology equipment and Measurement System Analysis (MSA).
Ability to work occasional evenings/weekends as needed.
Ability to travel up to 10%.

Nice To Haves

Advanced degree.
Experience scaling products in low-volume, high-mix manufacturing environments (capital equipment focus preferred).
Knowledge of GMP/GDP practices.
Experience with Agile PLM systems.
Understanding of engineered materials and manufacturing methods.
Background in robotics or large capital equipment assembly.
Experience with process validation planning/execution (IQ/OQ/PQ protocols and reports).
Prior experience in medical robotics or regulated environments.
Familiarity with ISO 13485, 21 CFR 820, and IEC 60601-1 standards.

Responsibilities

Provide leadership for NPI and Manufacturing Engineering for Ottava Capital Equipment.
Develop internal procedures to support the transition from concept and prototype to production, including BOM creation and refinement, engineering workflows, and documentation.
Lead development of repeatable, capable manufacturing processes with emphasis on mechanical assembly and testing of electromechanical components and subassemblies.
Drive technical innovation in manufacturing process technologies to achieve cost, safety, quality, and delivery objectives.
Implement Design for Excellence (DFX) improvements to enhance product quality, manufacturability, and reduce cost and time to market.
Plan and implement capacity strategies for early and future product lifecycle stages.
Design and improve manufacturing equipment, assembly tools, and test fixtures through capital investment initiatives.
Manage engineering resources to ensure timely and accurate project completion.
Build, coach, and mentor a high-performing engineering team, holding them accountable for results.
Collaborate with technical leaders on cross-functional initiatives to enhance organizational capability and efficiency.
Stay current with industry trends and best practices to strengthen team technical expertise.