Neurovascular Medical Device Manufacturing Engineer

Actalent; Minneapolis (MN); On-site; USD 66,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off / PTO

Job summary

Actalent seeks an engineering professional to support manufacturing of medical devices in Minneapolis. You will focus on maturation and stabilization of a Neurovascular device, resolve daily production issues, and improve cost, yield, and process efficiency.

The role involves validation activities, cross-functional teamwork, and ensuring quality across processes, materials, and equipment used to manufacture endovascular catheters. On-site presence is required.

Qualifications

• Experience in medical device manufacturing.
• Familiar with catheter product design, manufacturing processes and applications.
• Summarizes, analyzes, and draws conclusions from test results.
• Proficient with MS Office (Word, Excel, Access, Project and PowerPoint).

Responsibilities

• 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

Tools

MS Office

Job description

Actalent seeks an engineering professional to support manufacturing of medical devices in Minneapolis. You will focus on maturation and stabilization of a Neurovascular device, resolve daily production issues, and improve cost, yield, and process efficiency.

The role involves validation activities, cross-functional teamwork, and ensuring quality across processes, materials, and equipment used to manufacture endovascular catheters. On-site presence is required.