Industrial Engineer, Medical Device Manufacturing
Overview
You will own manufacturing process development for a recently acquired surgical device startup, scaling from prototype to production. You will work with a small team in Maple Plain, MN, directly impacting product quality and patient outcomes. This role focuses on Lean manufacturing, continuous improvement, and capacity modeling. You will partner with Operations, Quality, Supply Chain, and R&D to optimize workflows. The position demands 5+ years of industrial engineering experience in regulated medical device environments. You will drive cost reduction and efficiency gains while maintaining compliance with the Quality Policy.
What You'll Do10
- 1Lead continuous improvement initiatives using Lean manufacturing principles to increase productivity and reduce waste.
- 2Analyze manufacturing workflows, labor utilization, and line balancing to maximize throughput and resource efficiency.
- 3Develop capacity models, production strategies, and staffing plans to support customer demand and business growth.
- 4Drive cost reduction through cycle-time improvements, standardized work, and enhanced process efficiency.
- 5Monitor key manufacturing performance metrics, identifying trends to improve safety, quality, delivery, and cost.
- 6Conduct time studies, value stream mapping, and process analyses to identify bottlenecks and improve material and information flow.
- 7Lead structured problem-solving and root cause analysis to eliminate production constraints.
- 8Partner with Operations, Quality, Supply Chain, and R&D to improve manufacturability and scalability.
- 9Support process validation, change management, and continuous improvement activities for compliant manufacturing operations.
- 10Manage strategic improvement projects from concept to implementation, delivering measurable gains in productivity and cost performance.
Requirements9
- 15+ years of engineering experience in manufacturing industrial engineering.
- 2Hands-on experience scaling products from prototype to production.
- 3Skilled in fixture and tooling design and implementation.
- 4Strong CAD skills, with SolidWorks proficiency desired.
- 5Familiarity with regulated medical device environments.
- 6Knowledge of continuous improvement tools such as Lean and DMAIC.
- 7Familiarity with 5S and DMADV.
- 8Strong problem-solving skills, attention to detail, and self-starter with minimal supervision.
- 9Ability to lift up to 30 pounds and wear clean room clothing in a cleanroom environment.
Salary Insight
$96 - $100k per year
Location
Required Skills
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