Manufacturing Engineer

Job Title

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.

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.

Skills

Manufacturing engineering, Medical device, Process improvement, Process engineering, Manufacturing process, Continuous improvement, Lean manufacturing, Six sigma, Validation, neurovascular, equipment maintenance, equipment repair, equipment calibration, equipment validation, troubleshooting machinery, design for manufacturability

Top Skills Details

Manufacturing engineering, Medical device, Process improvement

Additional Skills & Qualifications

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.

Experience Level

Intermediate Level

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Job Type & Location

This is a Contract to Hire position based out of Minneapolis, MN.

Pay and Benefits

The pay range for this position is $48.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and…