Intuitive Surgical Careers
Senior NPI Manufacturing Engineer
Primary Location: United States-California-Santa Clara County-Sunnyvale
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Primary Function of Position:
A Senior Manufacturing Engineer builds and owns the manufacturing line for New Product Introductions (NPI) as well as the support, improvements, modifications and further deployment for sustaining production.
The ideal candidate has experience as a critical member of the team that develops, specifies, builds test and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability and cost for vision cameras, catheters, lumens, and leak tight connectors. This position requires high technical competence along with being a team player, self-starter, quick study, possessing a can-do attitude.
Roles and Responsibilities:
- Design, document, assemble, qualify and introduces production processes, assembly, test, inspection fixtures and equipment for vision cameras, catheters, lumens, and leak tight connectors.
- Strong CAD skillset with vision for electro-mechanical fixtures design and implementation.
- Takes ownership of new 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, work flow processes and detailed MPI work instructions.
- Uses the Agile ACCS creating and modifying BOM’s, Travelers, EFTs and MPIs including ECO/NCO/MCO writing, reviewing and implementation.
- 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.
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
- Mentors and sets project tasks for Mfg Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.
- Building the manufacturing line could either be internal to ISI or external at a supplier.
- Supports, maintains, improves modifies and further develops the manufacturing line as needed for sustaining production.
- Other reasonable assigned duties.
- 4 yr. degree in Mechanical Engineering or equivalent.
- 8+ years experience as design or manufacturing engineer supporting product with significant mechanical content. (MSME with 5 years also considered).
- Demonstrated understanding of manufacturing processes including catheter manufacturing, leak testing, adhesive processes, injection molding, machining, and Process Engineering capability.
- Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
- Electromechanical new product development experience preferred.
- 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.
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.