Job Description

Manufacturing Engineer II

Position Type: Contract, Non-Exempt

Position Overview

We are seeking an experienced Manufacturing Engineer to support manufacturing operations within a highly regulated Class III medical device environment. This position will take ownership of complex manufacturing engineering initiatives, provide technical leadership, and partner with cross-functional teams to improve processes, manage changes, and ensure manufacturing activities meet quality and regulatory requirements.

The ideal candidate will bring strong hands-on experience supporting Class III medical device manufacturing, including process validation, risk assessment, process controls, supplier changes, and project execution. This role requires someone who can proactively identify potential issues, develop solutions when established precedent may not exist, and successfully manage multiple priorities in a fast-paced manufacturing environment.

Key Responsibilities

• Provide manufacturing engineering support for Class III medical device manufacturing operations.
• Lead and take ownership of complex technical manufacturing engineering projects and initiatives.
• Develop, execute, and support process validation activities, including IQ, OQ, and PQ.
• Conduct and support risk assessments and establish appropriate manufacturing process controls.
• Identify and anticipate manufacturing issues and recommend effective technical solutions.
• Apply creative problem-solving and engineering judgment when established methods or precedent may not exist.
• Manage project timelines, deliverables, priorities, and dependencies across multiple concurrent projects.
• Partner closely with Quality, Operations, R&D, Supply Chain, suppliers, and other cross-functional stakeholders.
• Manage and support supplier changes and evaluate their impact on manufacturing processes, quality, and related systems.
• Support continuous improvement initiatives utilizing Lean, Six Sigma, GMP, and other manufacturing methodologies.
• Participate in technical and peer reviews to confirm engineering approaches, rationale, and verification/validation activities.
• Ensure engineering activities are performed in accordance with applicable quality systems, regulatory requirements, and manufacturing standards.

Qualifications

• Must have previous catheder expereince
• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Software Engineering, or a related engineering discipline.
• Strong knowledge and hands-on experience with process validation (IQ/OQ/PQ).
• Experience with risk assessments, process controls, and regulated manufacturing practices.
• Demonstrated experience managing engineering projects, project timelines, and multiple concurrent priorities.
• Experience supporting and managing supplier changes.
• Proven ability to work effectively with both internal and external stakeholders.
• Strong cross-functional collaboration, communication, technical problem-solving, and project management skills.
• Experience working with manufacturing methodologies and quality systems such as Lean, Six Sigma, and GMP.

Work Schedule & Location

This position is onsite in Minnetonka, Minnesota. The role is classified as non-exempt, and hours worked over 40 per week will be paid at time-and-a-half.