Manufacturing Engineer

Intuitive • Sunnyvale, CA

3d

About The Position

Contribute technical manufacturing, equipment design, and project management skills to a manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role supports refinement of electromechanical components, assemblies, process documentation, tooling, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic instruments.

The Manufacturing Engineer develops and improves manufacturing processes and equipment, supports production quality and capacity, and helps ensure compliance with medical-device quality-system requirements. The position also works with production personnel, suppliers, and cross-functional stakeholders to resolve issues and meet production goals.

Requirements

• Bachelor of Science degree in an engineering discipline.
• Excellent organizational skills and ability to manage multiple fast-paced assignments simultaneously.
• Ability to communicate effectively and professionally across technical disciplines and cultures with stakeholders including management, peers, customers, and suppliers.
• Ability to solve complex technical problems involving equipment and/or manufacturing processes.

Nice To Haves

• Master of Science degree in an engineering discipline.
• Two years of experience in NPI, manufacturing, or design engineering supporting complex mechanism manufacturing.
• Knowledge of manufacturing processes such as machining, injection molding, metal injection molding (MIM), crimping, welding, soldering, or adhesive joining.
• Quantitative process-development skills involving (p)FMEA, tolerance analysis, Design of Experiments (DoE), Statistical Process Control (SPC), Gage Repeatability and Reproducibility (GR&R), and CpK.
• Experience with Mechanical CAD (SolidWorks) and PLM (Agile) software.
• Prior experience with medical-device Design Control processes.
• Experience in an ISO 13485, ISO 9001, or medical-device manufacturing environment.

Responsibilities

• Contribute to a collaborative team focused on continuous improvement.
• Use Design for Manufacturing/Assembly (DFx) to develop product architecture that optimizes reliability, quality, and cost.
• Specify, design, document, and procure equipment needed for process steps.
• Plan and budget for production equipment needed to meet manufacturing capacity requirements.
• Define lean manufacturing process flows to maximize production efficiency.
• Author process FMEAs to identify potential manufacturing defects and reduce risks to patient safety.
• Validate manufacturing equipment and processes for efficacy and compliance with applicable requirements.
• Maintain and improve production quality, yield, cost, and capacity.
• Maintain medical-device quality-system compliance, including corrective-action closure, discrepant-material disposition, and Engineering Change Order implementation.
• Evaluate and help select suppliers for mechanical parts when required, and help resolve supplier quality issues.
• Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness.
• Address production-line support issues and document and report process variances, problems, issues, or concerns.
• Provide production personnel with expectations and regular performance feedback during the production process.
• Understand, train personnel on, and enforce applicable Department Operating Procedures and Standard Operating Procedures.
• Maintain accessible, up-to-date training records for MPIs and Quality System documents.
• Assist with setting and attaining quarterly and annual production goals.
• Learn and enforce company safety policies and practices.
• Participate in quality-improvement initiatives, providing feedback to identify root causes and solve problems.

Benefits

• Market-competitive compensation packages that include base pay, incentives, benefits, and equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level