Manufacturing Engineer II

Manufacturing Engineer II

Engineering

Lino Lakes, MN, US

• Added - 28 / 10 / 2025

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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.

Expansion Support & Facility Integration

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.

Technology & Equipment Implementation

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.

Collaboration & Cross-Functional Support

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.

Qualifications

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.

Skills & Abilities

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.

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.