Manufacturing Engineer, Stapler Reloads

Intuitive•Sunnyvale, CA

31d•Onsite

About The Position

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision stapling products for minimally invasive robotic surgery. The role requires active participation in the sustaining manufacturing engineering organization to refine mechanical components, assemblies, process documentation, tooling/fixtures/test tools, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic stapling products.

Requirements

Bachelors’ degree in Mechanical Engineering, related technical discipline, or related work experience.
High mechanical aptitude.
Strong oral and written communication skills.
Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments, GR&R) in data analysis for process development and problem-solving.
CAD experience (preferred SolidWorks).
Able to travel periodically to suppliers or Intuitive manufacturing sites.
Bachelor's degree in an engineering discipline with 2+ years of relevant experience, or equivalent practical experience.
Ability to lift 25 lbF

Nice To Haves

Prior experience working with complex mechanism manufacturing equipment
Prior experience with manufacturing packaging equipment
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment.
Skills in problem solving and using SolidWorks, Minitab, Python, SQL, Tableau and/or other SW tools for data analysis to identify root cause and drive corrective actions.
Use of Agile or similar lifecycle management system tool.

Responsibilities

Hands-on manufacturing sustaining support, setting up new manufacturing lines, duplication of manufacturing lines.
Provide production line support for day-to-day engineering issues on manufacturing lines.
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability
Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns.
Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions.
Create, maintain, and improve manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment.
Analyze manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
Ability to travel to international sites, including Mexico and Malaysia.