Manufacturing Engineer

About the role

The primary function of this position is to contribute technical manufacturing and equipment design skills to a dynamic development and manufacturing team that creates sensing platforms for minimally invasive robotic surgery. The role involves creating, maintaining, and improving manufacturing lines, providing production line support, designing fixtures, tools, and equipment, conducting testing, validating manufacturing equipment and processes, and providing technical support.

Responsibilities

• Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining Bill of Materials (BOMs), workflow processes, manufacturing plans, and detailed work instructions.
• Provide production line support for day-to-day engineering issues.
• Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment.
• Analyze manufacturing lines from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Validate and qualify manufacturing equipment and processes to production status leveraging standard qualification approaches (IQ/OQ/PQ).
• Provide production support of sustaining and startup manufacturing lines as needed.
• Conduct testing of software releases before deploying on manufacturing line.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement, and cost reduction.
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.
• Execute manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans.
• Maintain compliance with medical device quality system including corrective action closure and Change Order implementation.
• Provide technical support analyzing and/or performing failure analysis for discrepant production components, assemblies, and field returns.
• Maintain all documentation associated with the manufacturing line.
• Conduct SAP transactions relevant to manufacturing operations.
• Provide technician training and oversee specified manufacturing stations to ensure quality.

Qualifications

• Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
• Minimum 2 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content or advanced degree.
• Strong oral and written communication skills.
• Strong technical analytical and troubleshooting skills.
• Experience with Lean Manufacturing/Six Sigma principles.
• Proven ability to work on several fast-paced projects simultaneously.

Preferred Skills and Experience

• Mechanical CAD software experience (SolidWorks or equivalent).
• Programming skills.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment.
• Prior experience with complex device manufacturing.
• Prior responsibility for process, equipment, or product validation/verification.