Manufacturing Engineer

About the role

The role contributes to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The focus is on refining electro-mechanical components, assemblies, process documentation, tooling, and test methods to enhance efficacy, reliability, manufacturability, and cost for surgical robotic instruments.

Responsibilities

• Contribute to a collaborative team, which is focused on continuous improvement
• Employ Design for Manufacturing/Assembly (DFx) to develop optimal product architecture in terms of reliability, quality, and cost
• Specify, design, document, and procure the equipment necessary to perform each process step
• Plan, budget, and provide the production equipment necessary to meet manufacturing capacity requirements
• Define lean manufacturing process flows to maximize production efficiency
• Author process FMEA’s to identify and address potential manufacturing defects and minimize risks to patient safety
• Validate manufacturing equipment and processes to ensure efficacy and compliance with applicable requirements
• Maintain and improve production quality, yield, cost, and capacity
• Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition, and Engineering Change Order (ECO) implementation
• Evaluate and help in the selection of suppliers for mechanical parts if required
• Help resolve supplier quality issues
• Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness
• Address line support issues as they arise; Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process
• Provide production personnel with expectations and performance feedback regularly in the production process
• Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System
• Maintain up-to-date and accessible training records for MPIs and Quality System documents
• Aid in setting and attaining quarterly and annual production goals
• Learn and enforce company safety policies and practices
• Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving

Qualifications

• Excellent organizational skills; able to manage multiple fast-paced assignments simultaneously
• Ability to communicate effectively and professionally across a range of technical disciplines and cultures with a broad slate of stakeholders, including management, peers, customers, and suppliers
• Solution-oriented approach to solving complex technical problems with equipment and/or manufacturing processes
• Bachelor's degree in engineering discipline required
• Master's degree in engineering discipline preferred
• Experience in NPI, manufacturing, or design engineering supporting Mid-high volume complex mechanism manufacturing experience
• Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, soldering, or joining with adhesives
• 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 the Design Control processes for medical devices
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment

Preferred Skills and Experience

• 1-3 years of experience in NPI, manufacturing, or design engineering supporting Mid-high volume complex mechanism manufacturing experience
• Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, soldering, or joining with adhesives
• 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 the Design Control processes for medical devices
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment