Manufacturing Engineer

Job Description

We are seeking a skilled Manufacturing Engineer to perform engineering activities that support the manufacturing of both commercial and non-commercial finished medical devices. The primary responsibility for this role will be to support the maturation and stabilization of a newly launched Neurovascular device. The role involves investigating and resolving daily production issues involving equipment and processes, identifying opportunities to improve cost, yield, and process efficiencies, and turning ideas into realization. The engineer will also perform validation activities associated with process or material changes and provide technical information to development teams concerning manufacturing or processing techniques, materials, properties, and process engineering planning.

Responsibilities

• Provide daily support for products, processes, materials, and equipment to achieve production goals.
• Build quality into all aspects of work by maintaining compliance with 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 the appropriate level of testing required per internal procedures, customer alignment, and regulatory acceptance requirements.
• Work with purchasing to optimize supply chains, recommend projects to reduce risk and/or cost, and develop long-term commodity strategies.
• Design, implement, and monitor a Statistical Process Monitoring system.
• Monitor daily yields and act immediately to investigate and resolve issues to meet scrap and output goals.
• Design, procure, and fabricate equipment tooling and fixtures.
• Troubleshoot existing products/process problems related to design, material, or processes.
• Prepare validation protocols and reports to communicate results and conclusions.
• Lead cross-functional project teams as necessary.
• Identify, implement, and manage equipment, labor, and cycle time requirements to support production goals.
• Train and/or provide work direction to operators/technicians.
• Perform or support TMVs.
• Identify and investigate manufacturing issues (non-conformances) with root cause analysis and disposition production material through the NCMR Process.
• Notify QA/QC of any observed or reported product quality issues so appropriate action may be taken.

Essential Skills

• 3+ years of experience in medical device manufacturing, specifically with ISO13485 standards.
• Experience in manufacturing process improvement and equipment sustainability.
• Proficiency in process improvement techniques, including lean manufacturing and Six Sigma.
• Experience in equipment maintenance, validation, material control, quality control, and troubleshooting.
• Familiarity with catheter product design, manufacturing processes, and applications.
• Strong proficiency in MS Office (Word, Excel, Access, Project, and PowerPoint).

Additional Skills & Qualifications

• Experience with supply chain processes.
• Ability to summarize, analyze, and draw conclusions from test results.