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Sr. Manager, NPI Manufacturing Engineering
4 months ago
Job Description
Primary Function:
The Future Forward group within Intuitive Surgical is searching for a Sr. Manager, NPI Manufacturing Engineering to drive the development of manufacturing processes and equipment, to set up the pilot manufacturing line, and to support manufacturing of systems, instruments, and accessories for early feasibility studies and initial launch of a new robotic surgical platform. This role is an exciting opportunity to help define the eventual product from early prototypes through clinical trials and into product launch.
Roles and Responsibilities:
The primary roles of the Sr. Manager will include:
Provide strategic and technical leadership to the manufacturing engineering team
Establish group and team member goals, priorities, and metrics to meet organizational needs and assure team member development.
Establish manufacturing pilot lines for early-stage products for clinical trials
Set long-term manufacturing strategy for products that scale to commercialization, including:
Establish BOM structure for efficient production of assemblies and subassemblies
Establish DFX structure and manufacturing processes to assure products are viable in the long-term
Support development of strategic supplier partnerships
Evaluate process automation requirements and equipment
Define needs for EFT’s and team to develop and support them
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.
Plan, budget and staff projects, tracking performance throughout.
Review, evaluate & manage process risk in the manufacturing environment (PFMEA) and associated mitigations. Oversee the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ)
Work with Quality Engineering group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
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