Senior Manufacturing Engineer

Primary Function of Position

Essential Job Duties

• Lead duplication, line transfer, and operational manufacturing line activities.
• Provide daily engineering support for existing in-house manufacturing lines.
• Execute continuous improvement projects for product quality, throughput, and cost. Utilize analytical objective data and statistical analysis to establish metrics and to inform goals and priorities.
• Lead root cause investigation and drive dispositions for assembly-related defects.
• Support implementation of design improvements to existing products, including: Lead Design Verification and Validation (V&V) builds Coordinate cut-in/implementation in production
• Lead Design Verification and Validation (V&V) builds
• Coordinate cut-in/implementation in production
• Design and implement assembly/test fixtures to optimize cycle time, repeatability and consistency of complex assembly operations.
• Specify and refine BOMs, workflows/travelers, and detailed work instructions.
• Collaborate and communicate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to sustain and optimize processes and line performance.
• Create and revise manufacturing-related validation and risk documents including IQ/OQ/PQ/PPQ protocols, Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.

Required Skills and Experience

• Strong 3D modeling/CAD experience (SolidWorks preferred)
• Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.
• Familiarity and experience with the application of lean principles.
• Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
• Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.
• Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solving.
• Effective communication skills in Spanish and English (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

Preferred Skills and Experience

• Experience in mid-volume manufacturing of single-use and resposable medical 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.
• 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 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.
• Mandatory Notices
• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
• Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
• For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
• 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.
• This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.
• 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 compensation ranges are listed.