Job Summary:

This position will be an integral part of our medical technology company that develops and manufactures innovative medical devices. This position works with a cross-functional team from Engineering, Manufacturing and Quality to validate, launch and scale device and consumable manufacturing. This position will support continuous improvement activities in the areas of process, labor and cost. The Manufacturing Engineer will provide process development and validation expertise for the Manufacturing Team to support the development and scale of new products and accessories for patient monitoring technologies.

Duties & Responsibilities:

• Plans and directs assigned project activities. Performs both process development and validation activities.
• Leads team activity to modify plans as appropriate if problems arise and improves/supports existing processes.
• Must work with limited supervision and will be involved in and have input to project planning.
• Clearly communicates directions. influences people in adopting the best solutions, tools, working practices and promotes cooperation in defining an excellent technical product.
• Directs and facilitates the validation of manufacturing processes to assure process and product reliability. Leads the development of validation protocols and reports.
• Interfaces with technical peers and senior level managers to maintain mutual understanding of product development needs, regulatory and production requirements.
• Generates complete documentation for validation of manufacturing processes and associated manufacturing processes (work instructions, DHR’s, maintenance and calibration procedures, etc.)
• Develops systems and processes for high volume production.
• Designing and implementing automated processes.

Minimum Qualifications and Experience:

• BS in Mechanical Engineering or related field.
• 10+ years Manufacturing Experience in the medical device field.
• Experience with new production lines and processes from start up through scale.
• Experience in taking a major device from development to customer shipment.
• High volume consumables and cost of goods reduction experience
• Knowledge of standard assembly techniques in manufacturing and associated validation approaches
• Manufacturing experience working in cleanrooms and associated operating requirements.
• Advanced understanding and use of statistical analysis principles and tools (Minitab, etc.) as they relate to data analysis and testing reports
• Working knowledge with sterilizations processes and sterilization vendors
• Experience in writing, setup and control of documentation systems.
• Product packaging experience
• Excellent conceptual, analytical, and problem-solving ability.
• Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering and manufacturing personnel.
• Experience working with manufacturing and automation vendors
• Experience in leading projects to completion
• Prior Medical device manufacturing experience, with working knowledge of:

1. FDA 510(k) approval process
2. ISO standards
3. GMP regulations

• Experience working in both large structured and small entrepreneurial organizations.

Desired Qualifications:

• Experience working with microliter volume pumps and actuation.
• Knowledge of biomedical materials (e.g., metals, plastics, adhesives).
• Experience with site transfers.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.