Summary:

Performs engineering activities to support manufacturing of commercial and non-commercial finished medical devices. Primary responsibility for this role will be supporting maturation and stabilization for a newly launched Neurovascular device. Investigates and resolves daily production issues involving equipment and process. Identifies opportunities to improve cost, yield and process efficiencies and turns ideas into realization. Performs validation activities associated with process or material changes. Exercises independent judgment in planning and organizing work; monitors performance and reports status. Provides technical information to development teams concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning.

Essential Duties and Responsibilities (but are not limited to):

• Provides daily support of products, processes, materials, and equipment to achieve production goals.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Troubleshoot, repair, qualify or validate new and existing equipment used to manufacture endovascular catheters.
• Prepare testing and justification to support process, equipment and material changes.
• Determine appropriate level of testing required per internal procedures, customer alignment and regulatory acceptance requirements provided.
• Work with purchasing to optimize supply chains, recommend projects which reduce risk and/or reduce cost, and develop long-term commodity strategies.
• Design, implement and monitor Statistical Process Monitoring system
• Monitors daily yields and acts immediately to investigate and resolve issues to meet scrap and output goals.
• Designs, procures, and fabricates equipment tooling and fixtures.
• Performs troubleshooting on existing products/process problems as related to design, material, or processes.
• Prepares validation protocols and reports to communicate results and conclusions.
• May lead cross-functional project teams.
• Identifies, implements, and manages equipment, labor and cycle time requirements to support production goals.
• Trains and/or provides work direction to operators/technicians.
• May perform or support TMV’s.
• Identify/Investigate Manufacturing issues (non-conformances) with root cause analysis and disposition production material through NCMR Process.
• Responsible for notifying QA/QC of any observed or reported product quality issues so that appropriate action may be taken.

Technical Skills:

• Experience in medical device manufacturing.
• Familiar with catheter product design, manufacturing processes and applications.
• Summarizes, analyzes, and draws conclusions from test results.
• Highly proficient with MS Office (Word, Excel, Access, Project and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications.
• Ability to accurately prioritize and execute with minimal direction.

Conceptual Skills:

• Creative problem solver coupled with good judgment.
• High attention to detail and accuracy.
• Ability to manage and prioritize multiple tasks and remain focused on personal objectives.
• Strong interpersonal communication skills with the ability to effectively communicate across all levels and with external customers.
• Proven ability to work effectively alone and in a multi-disciplinary team.

Education/Experience:

• Bachelors of Science Degree in Engineering discipline
• 5+ years of related experience
• 2+ years of experience in medical device manufacturing

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.