Manufacturing Engineer

Manufacturing Engineer

The Manufacturing Engineer will perform engineering activities to support the manufacturing of both commercial and non-commercial finished medical devices. The primary responsibility will be to support the maturation and stabilization of a newly launched Neurovascular device. This role involves investigating and resolving daily production issues involving equipment and processes, identifying opportunities for cost, yield, and process efficiencies, and performing validation activities related to process or material changes.

Responsibilities

• Provide daily support of 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 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 Statistical Process Monitoring systems.
• 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.
• Perform troubleshooting on existing product/process problems related to design, material, or processes.
• Prepare validation protocols and reports to communicate results and conclusions.
• Lead cross-functional project teams as needed.
• 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 Test Method Validations (TMVs).
• Identify and investigate manufacturing issues (non-conformances) with root cause analysis and disposition production material through the Non-Conforming Material Report (NCMR) process.
• Notify QA/QC of any observed or reported product quality issues so that appropriate action may be taken.

Essential Skills

• 3+ years of experience in medical device manufacturing.
• Experience with ISO13485 standards.
• Proficiency in manufacturing process improvement.
• Experience in manufacturing equipment sustainability.
• Knowledge of process improvement, continuous improvement, and lean manufacturing.
• Familiarity with Six Sigma methodologies.
• Expertise in equipment maintenance, validation, and material control.
• Strong quality control and troubleshooting skills.
• Understanding of validation and supply chain processes.

Additional Skills & Qualifications

• Familiarity with catheter product design and manufacturing processes.
• Ability to summarize, analyze, and draw conclusions from test results.
• High proficiency in MS Office (Word, Excel, Access, Project, and PowerPoint).
• Strong internet research skills.

Work Environment

The work environment is very relaxed with a family-first mindset. The team fosters a sense of belonging, and everyone feels part of the group. The company organizes team lunches, outings, happy hours, and events to include everyone. There is some flexibility to work from home depending on the workload and role. The organization values a flexible schedule and prioritizes work/life balance.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $43.00 - $62.00/hr. 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 Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Brooklyn Park, MN.

Application Deadline

This position is anticipated to close on Jan 23, 2026.