B.S. in Mechanical Engineering or related field; M.S. preferred.
8+ years of experience with a B.S. or 6+ years with an M.S. in process or manufacturing engineering.
Proven experience in designing complex mechanical fixtures and custom tooling for precision manufacturing.
Strong 3D modeling skills, preferably in SolidWorks, with expertise in GD&T and FEA modeling.
Deep understanding of component manufacturing processes like injection molding and machining.
Technical problem-solving skills with proficiency in statistical methods for data analysis.
Responsibilities
Provide daily engineering support for existing manufacturing lines.
Drive continuous improvement of mechanical fixtures and processes using data analysis.
Design and implement robust mechanical fixtures to enhance assembly repeatability.
Lead investigations into assembly defects and drive corrective actions.
Support quality compliance and troubleshoot equipment malfunctions.
Collaborate with cross-functional teams to meet project objectives for new product introductions.
Mentor junior engineers and lead continuous improvement initiatives.
Benefits
Market-competitive compensation packages including base pay and incentives.
Opportunities for professional development and mentorship.
Collaborative work environment with cross-functional teams.
Potential for travel to suppliers and manufacturing sites.
Focus on innovation in medical device manufacturing.
Full Job Description
Job Description
Primary Function of the Position
Contribute your technical mechanical, manufacturing, and problem-solving skills to a dynamic team creating precision instruments for the daVinci SinglePort (SP) platform. This highly skilled mechanical 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 mechanical fixtures and processes to improve product quality, throughput, and cost. Utilize objective data and statistical analysis to inform and drive decisions.
Ideate, prototype, and implement simple, robust mechanical fixtures and tooling designed to error-proof complex assembly steps, take operator skill levels and manual technique out of the equation, and maximize production repeatability.
Lead root cause investigations and drive dispositions for assembly-related defects using Product and Process FMEAs as guidance.
Support quality system compliance including ECO review and implementation, discrepant material dispositions, nonconformance evaluations, and quality notifications.
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)
Lead Design Verification and Validation (V&V) builds
Coordinate cut-in/implementation in production.
Provide manufacturing feedback for supplier change requests (SCRs).
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), and general assembly
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 Test method validation.
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 objectives 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 decisions 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
Advanced fixture and tooling design experience: Proven track record of designing complex mechanical fixtures and custom tooling for precision manufacturing environments.
Integration with standard equipment: Hands-on experience developing custom tooling designed for integration into standard manufacturing equipment (e.g., presses, crimpers, heat stakers, ultrasonic welders).
Strong mechanical aptitude and fundamentals: Deep knowledge of mechanical design principles, fabrication methods, precise material selection, and surface treatments to optimize tooling performance.
Advanced CAD, GD&T, and Analysis: Strong 3D modeling/CAD experience (SolidWorks preferred), expert application of Geometric Dimensioning and Tolerancing (GD&T), Tolerance stack-up analysis, and proficiency in FEA modeling.
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.
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
Abhility to lift, maneuver, and troubleshoot fixtures and tools
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.
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.
About Intuitive Surgical, Inc
Intuitive Surgical, Inc. is an American corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System. The company is part of the NASDAQ-100 and S&P 500. Intuitive Surgical has installed more than 5,000 surgical systems worldwide, and has more than 4,000 employees.
