Senior Manufacturing Engineer

Intuitive•Sunnyvale, CA

22d•$132,900 - $225,000•Onsite

About The Position

Individuals in this role will establish and develop manufacturing processes for new product development accessories, as well as provide daily support for manufacturing operations and mechanical design improvements for existing accessories. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling, manufacturing equipment, and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments and accessories.

Requirements

BS / MS degree in Engineering discipline or equivalent work experience.
5-10 years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.
Prior responsibility and experience with process development and process parameter development (DOE, critical parameter management).
Experience with equipment selection, test method development, and working closely with equipment/automation vendors.
Experience with product and process validation & verification, specifically in a medical device or similarly controlled industry.
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
Great attitude, eager, willing/able to take initiative, works well with others in team environment.

Nice To Haves

Experience with catheter manufacturing processes and leak test development a plus.
Experience with high volume automated assembly and plastic forming (injection molding, transfer molding) and joining processes (laser welding, ultrasonic welding, heat staking) a plus.
CAD experience (preferred Solidworks).
New product introduction/development desirable.
Robotics knowledge a plus.
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
Prior experience designing automated equipment, complex mechanism manufacturing is a plus

Responsibilities

Develop manufacturing assembly processes and test methods for new product development accessories.
Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
Analyze instrument/accessories manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
Create, maintain and improve pilot “mid to high volume” manufacturing assembly lines, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.
Provide production support through successful and sustained project launch.
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 of new products.
Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.