Manufacturing Engineer

Manufacturing Engineer
Location: Osseo, MN
Position Type: Full Time – Onsite

The Manufacturing Engineer supports new injection molding and additive manufacturing programs by developing and validating pre- and post-molding processes (e.g., labeling, packaging, fixturing, welding, gluing, leak testing, washing) and ensuring production readiness. This role collaborates with tooling, quality, and processing teams to define process requirements, author IQ/OQ/PQ protocols, and manage engineering change orders (ECOs) and bills of materials (BOMs).

Primary Mission:
Ensure successful implementation of manufacturing processes for new programs, meeting quality standards and production timelines through efficient solutions and thorough documentation.

Key Responsibilities:

• Develop and optimize pre- and post-molding processes and parameters.
• Collaborate on production ramp-up, factory layout, and automation opportunities.
• Initiate ECOs, set up BOMs, and manage ERP/QMS workflows.
• Author and execute IQ/OQ/PQ protocols, support First Article Inspections (FAI), and define critical process/quality parameters.
• Train leads on new procedures and participate in CAPA/customer complaint resolution.

Required Skills:

• Expertise in manufacturing process development and validation (IQ/OQ/PQ).
• Knowledge of CAD (SolidWorks preferred), ERP/QMS systems (IQMS a plus), and label/inspection tools (e.g., Minitab, CMM).
• Experience with pre/post-molding operations and lean/Six Sigma principles.
• Strong analytical, problem-solving, and communication skills.
• Familiarity with FDA, ISO 13485/9001 standards is a plus.

Education/Experience:

• Bachelor’s in Manufacturing, Mechanical, or Industrial Engineering (or related field) preferred; ~3-5 yrs. exp.
• Experience in injection molding, 3D printing, or regulated industries (e.g., medical, aerospace) is a plus.

Salary ~$80k-$95k DOE, plus 401k, stock, and health care benefits