Job Title: Experienced Manufacturing Engineering Technician

Job Description

The Manufacturing Engineering Technician supports daily manufacturing operations, process development, and qualification activities for production tissue heart valves at a fast-paced startup environment in Plymouth, MN. This role focuses on regulated medical device manufacturing and involves close collaboration with cross-functional manufacturing and engineering teams to ensure reliable, efficient, and compliant production processes.

Responsibilities

• Provide daily technical support for operations in the metals, valve assembly, and packaging areas to ensure smooth and efficient production.
• Identify, investigate, and implement corrective actions for manufacturing-related issues to improve product quality and process reliability.
• Perform equipment setup and execute corrective, preventive, and calibration maintenance as needed to maintain optimal equipment performance.
• Install and validate manufacturing equipment and processes in accordance with required validation requirements and regulatory standards.
• Develop tooling and fixtures to support new and existing manufacturing processes and improve production efficiency.
• Plan, order, and coordinate the procurement of equipment, tools, and fixtures to support manufacturing operations and process improvements.
• Manage and maintain manufacturing equipment, including troubleshooting issues, performing preventive maintenance activities, and supporting asset management.
• Support floor-level material and tool organization using Kanban replenishment systems to maintain efficient and orderly production areas.
• Participate in process development projects by working closely with engineering teams on process improvements and optimization initiatives.
• Collaborate with engineering on projects and continuous improvement ideas to enhance manufacturing processes and product quality.
• Adhere to and support general safety rules, manufacturing procedures, company policies and procedures, and applicable regulations.
• Ensure compliance with Quality System Regulation (QSR) and ISO standards in all manufacturing and validation activities.

Essential Skills

• 5+ years of experience in regulated manufacturing environments, preferably within the medical device industry.
• Strong experience in medical device manufacturing, including familiarity with regulated production environments and quality systems.
• Hands-on experience with equipment validation, including installation, operational, and performance qualification activities.
• Demonstrated troubleshooting skills for manufacturing processes and equipment issues.
• Experience with continuous improvement and process improvement initiatives in a manufacturing setting.
• Knowledge of lean manufacturing principles and their application on the production floor.
• Experience in manufacturing engineering or process engineering roles supporting production operations.
• Ability to perform equipment setup, corrective maintenance, preventive maintenance, and calibration maintenance.
• Understanding of QSR and ISO standards and their application in a regulated manufacturing environment.
• Ability to work effectively in a fast-paced startup environment and collaborate with cross-functional teams.

Additional Skills & Qualifications

• Experience with manufacturing processes for metals, valve assembly, and packaging operations.
• Past in manufacturing process development and optimization.
• Experience with tooling and fixture development to support new and existing processes.
• Familiarity with Kanban systems for material and tool organization on the manufacturing floor.
• Experience planning and ordering equipment, tools, and fixtures to support production and engineering projects.
• Demonstrated ability to support maintenance and equipment management, including asset management activities.
• Strong communication skills to collaborate effectively with manufacturing and engineering teams.
• Comfort working as a technician with responsibility for supporting production and process improvement activities.

Work Environment

This role is primarily based on the manufacturing floor with limited desk time, providing a hands-on environment focused on production tissue heart valves in a regulated medical device setting. The position operates on a first shift schedule, Monday through Friday, from 7:00 a.m. to 3:30 p.m. You will work closely with cross-functional manufacturing and engineering teams in a fast-paced startup atmosphere that emphasizes collaboration, continuous improve