NPI Manufacturing Engineer

Published
May 13, 2022
Location
Sunnyvale, CA
Category
Job Type

Description

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect.We lead with inclusion and empower our team members to do their best work as theirmost authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together,let’s advance the world of minimally invasive care.
Job Description Primary Function of Position:
Contribute your technical manufacturing engineering and problem-solving skills to a dynamic team creating precision instruments and accessories for the daVinci SinglePort (SP) platform. This highly skilled manufacturing engineer will support manufacturing lines for both mature and new single-use medical devices. Responsibilities include providing daily support for existing manufacturing lines as well as developing manufacturing equipment and processes for new products.

Roles & Responsibilities:

• Sustain existing manufacturing lines:
o Provide daily engineering support for existing in-house manufacturing lines.
o Drive continuous improvement of product quality, throughput, and cost using objective data and statistical analysis. Examples:
§ Optimize existing processes using statistical tools (Design of Experiments/DOE, Process Capability/Cpk, and Gage R&R).
§ Execute and document validation activities (IQOQPQ/PPQ) for new and modified processes.
§ Analyze historical production data to set quantitative goals and drive continuous improvement projects.
o Lead root cause investigation and drive dispositions for assembly-related defects using Design and Process FMEAs as guidance.
o Troubleshoot, resolve, and document equipment malfunctions in compliance with GXP and Intuitive Quality System requirements.
o Support implementation of design improvements to existing products, including:
§ Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA)
§ Lead Design Verification and Validation (V&V) builds
§ Coordinate cut-in/implementation in production

• Contribute to the development of efficient manufacturing lines for New Product Introduction of single-use medical devices for the daVinci SinglePort platform:
o Develop, document, and qualify (IQOQPQ/PPQ) new manufacturing and test processes.
o Design and implement assembly/test fixtures to increase repeatability of complex assembly operations including cable routing, plastics joining (e.g. ultrasonic welding, heat staking, snap fit, press fit), metals joining (e.g. laser welding, riveting, swaging, crimping).
o Specify and refine BOMs, workflows/travelers, and detailed work instructions.
o Collaborate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to meet project objectives including Design Verification & Validation and product launch. Examples include building prototype assemblies, training operators, identifying fixtures/tooling needed and conducting process validation.
o Create and revise manufacturing-related risk documents including Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.
Qualifications Skills/Job Requirements:
• Minimum B.S. degree in engineering or related technical discipline. M.S. preferred.
• 3+ years of experience as design, process, or manufacturing engineer supporting manufacturing process and equipment development and qualification (IQOQPQ/PPQ).
• Background in disposable medical device manufacturing and plastics joining methods is highly preferred.
• Technical problem solving skills with ability to identify root cause and drive corrective actions.
• Ability to employ statistical methods (Design of Experiments, Cpk, ANOVA) in data analysis for process development and problem-solving.
• Demonstrated understanding of component manufacturing processes (e.g. injection molding, transfer molding, thermoforming, machining, stamping, and MIM) is a plus.
• Effective communication skills (verbal, written, and presentation) and comfortable interacting with production technicians, product design engineers, planning, buyers, clinical engineers, and suppliers.
• Able to travel periodically to suppliers or Intuitive manufacturing sites.
• 3D modeling/CAD experience is a plus (SolidWorks preferred).
• Experience in medical device design controls and manufacturing (ISO 13485, FDA 21 CFR part 820) is a plus.
• Machine tool experience is a plus.

Additional Information All your information will be kept confidential according to EEO guidelines.Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
* Shift : * Day
* Travel : * 10% of the time
Travel Requirements:10% of the time Shift:Day

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