Manufacturing Engineer

Intuitive•Sunnyvale, CA

3d•$99,700 - $158,700•Onsite

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 participates in refining electro-mechanical components, assemblies, process documentation, tooling, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic instruments. The position supports continuous improvement and production operations, including designing and procuring equipment, planning production capacity, developing lean process flows, validating equipment and processes, and maintaining production quality, yield, cost, and capacity. It also contributes to medical-device quality-system compliance, supplier evaluation and issue resolution, production-line support, employee training, safety, and quality-improvement initiatives.

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 a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, soldering, or adhesive joining.
Quantitative process-development skills in areas such as (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
Experience with Mechanical CAD (Solidworks) and PLM (Agile) software.
Prior experience with Design Control processes for medical devices.
Experience in an ISO 13485, ISO 9001, or medical-device manufacturing environment.

Responsibilities

Contribute to a collaborative team focused on continuous improvement.
Apply Design for Manufacturing/Assembly (DFx) to develop product architectures optimized for reliability, quality, and cost.
Specify, design, document, and procure equipment required 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 and address 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 compliance with the medical-device quality system, including corrective-action closure, discrepant-material disposition, and Engineering Change Order (ECO) implementation.
Evaluate and help select suppliers for mechanical parts when required.
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 in the production process.
Understand, train personnel in, and enforce adherence to applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System.
Maintain current and accessible training records for MPIs and Quality System documents.
Assist in 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.