Sr. NPI Manufacturing Engineer

4 days ago

Sunnyvale, United States Intuitive Full time
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 their most 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 the Position

Contribute your technical manufacturing, design, 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 products. Responsibilities include providing daily support for existing manufacturing lines, continuous improvement efforts, as well as developing manufacturing equipment and assembly processes for new products.

Essential Job Duties
  • Sustain and improve existing manufacturing lines:
    • Provide daily engineering support for existing in-house manufacturing lines.
    • Own and drive continuous improvement of product quality, throughput, and cost. Utilize objective data and statistical analysis to inform and drive decisions.
    • Drive root cause investigations and drive dispositions for assembly-related defects using Product and Process FMEAs as guidance.
    • Troubleshoot, resolve, and document equipment and process malfunctions in compliance with GXP and Intuitive Quality System requirements.
    • Assist in line transfer and line duplication activities.
    • Support implementation of design improvements to existing products, including:
      • Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA)
      • Drive Design Verification and Validation (V&V) builds
      • Coordinate cut-in/implementation in production.
    • Support equipment and process qualification efforts (IQOQPQ and PPQs)
  • Contribute to the development of efficient manufacturing lines for New Product Introduction for medical devices for the daVinci SinglePort platform:
    • 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)
    • Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Gage R&R.
    • Specify and refine BOMs, workflows/travelers, and detailed work instructions.
    • Collaborate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to meet project priorities including Design Verification & Validation and product launch. Examples include building prototype assemblies, training operators, identifying fixtures/tooling needed and conducting process validation.
    • Create and revise manufacturing-related risk documents including Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.
  • Leadership Responsibilities:
    • Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining continuity of material supply.
    • Mentors and sets project tasks for Manufacturing Engineers on their specific project team, and on other teams as needed, to further company expertise & effectiveness.
    • Establish milestones, support, and success criteria for responsible projects. Drive outcomes and escalate key issues quickly maintaining stakeholder alignment.
    • Keep the organization's vision and values at the forefront of decision-making and action.
Qualifications

Required Skills and Experience
  • Exceptional 3D modeling/CAD experience (SolidWorks preferred)
  • Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.
  • Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.
  • Technical problem solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
  • Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solving.
  • 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.
Required Education and Training
  • Minimum B.S. Mechanical Engineering or related technical discipline. M.S. preferred.
  • Minimum 8+ years with a B.S or 6+ years with an M.S of experience as a process or manufacturing engineer supporting products with significant mechanical content.
Working Conditions
  • Ability to lift 50lbs.
Preferred Skills and Experience
  • Experience in mid-volume manufacturing of single-use devices or complex electro-mechanical assemblies is a plus.
  • Experience in medical device design controls and manufacturing (ISO 13485) is a plus.
  • Machine tool experience is a plus.


Additional Information

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 / Affirmative Action 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.

EEO and AA Policy

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

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