Senior Manufacturing Engineering Technician
This role supports daily manufacturing operations, process development, and qualification activities for production tissue heart valves at a fast-paced startup in Plymouth, MN. Focused on regulated medical device manufacturing, it 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.
Requirements
- 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 Qualifications
- Experience with manufacturing processes for metals, valve assembly, and packaging operations.
- Past involvement 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 improvement, and adherence to safety, QSR, and ISO standards. The environment involves regular interaction with production equipment, tools, fixtures, and Kanban-based material organization systems.
Pay
The pay range for this position is $30.00 - $38.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include the following for this temporary role:
- Medical, dental, and vision insurance
- Critical Illness, Accident, and Hospital coverage
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Schedule
First shift, Monday through Friday, from 7:00 a.m. to 3:30 p.m.