Senior Manufacturing Engineer

Intuitive•Sunnyvale, CA

30d

About The Position

This Senior Manufacturing Engineer will build and own the manufacturing line for New Product Introductions (NPI) as well as supports improvements, modifications and further deployment of sustaining production lines of catheter products. These products support Intuitive’s new robotic platform (Ion) for minimally invasive biopsy in the peripheral lung with an initial goal of improving the early diagnosis of lung cancer. The position participates in product development teams that specify, build, test and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability and cost. This position requires high technical competence along with being a team player, self-starter, and possessing a can-do attitude.

Requirements

Minimum 4 yr. degree in Mechanical Engineering or equivalent.
Minimum 8+ years’ experience as design or manufacturing engineer supporting product with significant mechanical content. (MSME with 5 years also considered).
Strong CAD skillset with vision for electro-mechanical fixtures design and implementation.
Uses the Agile ACCS creating and modifying BOM’s, Travelers, EFTs and MPIs including ECO/NCO/MCO writing, reviewing and implementation.
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.

Nice To Haves

Demonstrated understanding of catheter manufacturing processes including injection molding, machining, stamping, lamination, braiding, thermal bonding, laser bonding, tipping, extrusion handling, and process capabilities.
Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
Solid modeling/CAD experience (SolidWorks preferred).
Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
Excellent communication, organization, follow-up and documentation skills.
Comfortable interacting with technicians, engineers, and management all on a regular basis.
Strong technical skills in prototyping, tooling development and troubleshooting.
ISO9001 or experience in medical device manufacturing environment.
Specific supplier manufacturing knowhow depends on the specific area assigned.

Responsibilities

Design, document, assemble, qualify and introduces production assembly/test/inspection fixtures and equipment.
Takes ownership of new catheter products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering to enhance manufacturability and product cost.
Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflow processes and detailed MPI work instructions.
Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or as needed at suppliers.
Provides training and support to production technicians.
Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions (VR’s PL’s and EE’s).
Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
Mentors and sets project tasks for Manufacturing Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.
Supports, maintains, improves modifies and further develops the manufacturing line as needed for sustaining production, yield enhancement, and cost reduction.