Manufacturing Engineer II Job at Astrix Technology in Circle Pines
Astrix Technology, Circle Pines, MN, US
**Manufacturing Engineer II** Engineering Lino Lakes, MN, US + Added - 28/10/2025 Apply for Job With over three decades of expertise, we are a trusted leader in precision machining of specialty medical wire and tubing, delivering excellence from early-stage prototypes to full-scale production. Specializing in custom mandrels, precision components, and advanced finishing services, we are committed to quality, innovation, and process excellence- ensuring every product meets the highest medical industry standards for performance and reliability. The Manufacturing Engineer is responsible for optimizing production processes, improving efficiency, and ensuring high-quality operations in a precision machining environment. This hands-on role focuses on new product introductions, process development, waste reduction, problem-solving, and cost reduction initiatives, while also supporting the expansion to a second manufacturing site through facility layout, equipment selection, and process transfer activities-all in compliance with medical device quality and regulatory standards. Schedule: Monday-Friday, 7:30am-4:30pm Salary: 110k-130k/yr. Location: Lino Lakes, MN
- *Key Responsibilities**
- *Manufacturing Process Optimization & Support**
- Develop, implement, and improve manufacturing processes to enhance production efficiency, quality, and cost-effectiveness.
- Provide hands-on troubleshooting for production issues, identifying root causes and implementing corrective actions.
- Collaborate with engineering, production, and quality teams to ensure seamless process integration.
- Create and maintain process documentation, including work instructions, flow diagrams, pFMEAs, control plans, and SOPs.
- Support continuous improvement initiatives to drive operational excellence and waste reduction.
- Assist in planning and executing the expansion to a second manufacturing site.
- Contribute to facility layout design, equipment selection, and process flow optimization.
- Support process and equipment transfer activities while minimizing production disruptions.
- Ensure compliance with ISO 13485, FDA, and safety standards throughout expansion efforts.
- Identify and justify capital projects for new equipment and process improvements.
- Oversee installation, validation, and release of new manufacturing equipment.
- Implement automation, error-proofing, and lean manufacturing methods to enhance throughput and reduce costs.
- Serve as a key contributor to cross-functional teams focused on manufacturing excellence.
- Provide technical insights during design reviews, sales discussions, and new product development meetings.
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
- Minimum 5 years of experience in manufacturing engineering, preferably in medical device or other regulated industries.
- Proven experience in process development, validation, and continuous improvement.
- Experience supporting facility expansions or process transfers is highly desirable.
- Strong background in precision machining and value-added processes (e.g., laser welding, laser cutting, plating, cleaning/passivation).
- Familiarity with external finishing services such as passivation, heat treating, coatings, plating, electropolishing, anodizing, and welding.
- Hands-on troubleshooting and problem-solving capabilities for equipment and process issues.
- Proficiency with CAD software and ERP/MRP systems for manufacturing planning.
- In-depth understanding of regulatory requirements including ISO 13485, FDA, and GMP.
- Strong analytical, communication, and collaboration skills.