Manufacturing Engineer, Senior

Manufacturing Engineer, Senior Staff

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include:
Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guide wires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Manufacturing Engineer, Senior Staff to join our team. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets.

Summary:

• Works on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Demonstrates full use and application of standard principles, theories, concepts and techniques.
• Selects design direction or modifications of components of systems. Participates in decisions on scope of work, selection of equipment and length of task.
• Decides on design changes to meet revised specifications. Provides and develops solutions to problems of limited scope.
• Must be able to accomplish broad and complex assignments.
• May provide technical guidance to lower-level personnel.

Essential Duties and Responsibilities:

• Responsible for ensuring personal and company compliance with local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Properly document activities in accordance with the best engineering practices, company procedures, and regulatory requirements (technical reports).
• Work with R&D/Design/Development/Transfer Engineers or Customers to understand the products to be produced.
• Able to conduct basic to complex quality visual inspection of parts in accordance with process or other control procedures such as Work Standards.
• Responsible for cost effective manufacturing product/lines through the management of yield, material usage (BOM and consumables).
• Conducts engineering efforts to identify root cause analysis.
• Responsible for the development and implementation of standard manufacturing methods, process and efficiency improvements.
• Conducts engineering efforts to optimize medical component processing for manufacturing (time studies, working standards, process flows, etc).
• Conducts and documents time studies to establish performance standards.
• Executes cost analysis (material, labor and burden) as required.
• Analyzes and implements improvements to reduce product costs.
• Develops, implements and monitors manufacturing process controls and machinery modifications (re-engineering).
• Designs layouts for production lines.
• Independently performs most assignments with instructions as to the general results expected
• Responsible for design/development of equipment, tools or fixtures that meets health, safety and environmental standards set by the company for manufacturing methods.
• Participates and approves design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
• Setups and validates production lines for manufacturing as applicable.
• Leads product transfers, and new product introductions
• Provides technical supervisory and coordinates the work of engineers, draftspersons, technicians, and others who assist in the specific assignments.
• Builds business relationship with customer and/or suppliers.
• Investigate, respond and solve quality issues, or provides supports…