Manufacturing Engineering, Assembly

Job Description

Primary Function of Position Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in a manufacturing engineering organization in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.

Essential Job Duties

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 FMEAs 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.

Assist 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.

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