Manufacturing Engineer II

Imris•Chaska, MN

6d•Onsite

About The Position

As a leader in image guidance solutions, IMRIS Imaging, Inc. provides optimized, fully integrated image-guided therapy environments that address the important needs of patients, clinicians, and hospitals by delivering timely MRI and imaging data to clinicians for use during surgical or interventional procedures. The IMRIS Surgical Theatre enables intraoperative imaging directly within operating rooms. The Company also designs and manufactures proprietary head fixation devices, imaging coils and OR tables for use in this unique and multifunctional intraoperative environment. It is estimated that over 70,000 patients have benefited from lifesaving or life-extending procedures performed in an IMRIS Surgical Theatre. IMRIS will continue to integrate new intraoperative imaging technologies and shape the future of neurosurgery in operating rooms worldwide. We are searching for a Manufacturing Engineer II to join our team. This role will be performed on-site and is based in the Greater Twin Cities area at our Chaska, MN headquarters. Please note: There is no relocation offered for this role. The ideal candidate should currently reside in the Greater Twin Cities area. The Manufacturing Engineer II is a mid-level technical role responsible for developing, improving, and validating manufacturing processes for IMRIS products. This position combines hands-on problem-solving with process optimization and supports new product introduction activities. The Manufacturing Engineer II works independently on moderately complex projects, applying Lean and Six Sigma principles to enhance quality, efficiency, and compliance with medical device standards. This role also provides mentorship to junior engineers and collaborates cross-functionally to ensure manufacturability throughout the product lifecycle.

Requirements

Bachelor's degree in engineering, or equivalent experience.
3-6 years of experience in manufacturing engineering.
Knowledge of FDA, ISO 13485, and other regulatory requirements for medical devices preferred.
Advanced understanding of Lean principles and Six Sigma methodologies.
Experience with process validation, risk analysis, and documentation for regulated industries.
Familiarity with electro-mechanical assemblies, materials, and manufacturing processes.
Proficiency in Microsoft Office Suite and statistical analysis tools; CAD experience (SolidWorks, AutoCAD) preferred.
Excellent problem-solving, communication, and project management skills.
Excellent communication and teamwork abilities.
Ability to lead cross-functional teams and manage multiple projects simultaneously.
Experience with ERP/MRP systems and manufacturing execution systems (MES).

Responsibilities

Develop and improve manufacturing processes, documentation, and tooling to optimize quality, productivity, and cost.
Support new product introductions by preparing assembly instructions, process validations, and risk assessments.
Troubleshoot and resolve production issues using root cause analysis and corrective actions.
Collaborate with R&D, Quality, and Supply Chain teams to ensure design for manufacturability and compliance.
Conduct and document process validations in accordance with IMRIS QMS and regulatory requirements.
Lead small-scale Kaizen events and continuous improvement initiatives.
Train technicians and production staff on new or revised processes.
Assist in supplier qualification and evaluation for manufacturing readiness.
Prepare and maintain accurate documentation, including travelers, work instructions, and FMEAs.
Provide mentorship and technical guidance to Manufacturing Engineer I and technicians.
Travel to suppliers or customer sites as needed for technical support and audits.