Manufacturing & Process Development Engineer

Job Description

Fiagon NA, LLC designs, develops, manufactures, and markets advanced medical devices for use in the healthcare industry. Our business is expanding and we are seeking a Manufacturing / Process Development Engineer to support our increasing demand and implementation of new medical device products to market.

The qualified candidate will provide a role leading engineering initiatives in developing new product & manufacturing processes as well as support & implement improvements across several existing product manufacturing areas. This role will interface in a collaborative team-based environment with research & development, operations, quality, regulatory, sales, and marketing teams to support our existing business and drive the successful implementation & launch of new medical devices.

This role requires onsite work. There is a great amount of growth opportunity within the organization and the right candidate will have exposure to a large variety of internally manufactured products and opportunity to help shape the organization.

The responsibilities of this position include:

• Monitor performance of equipment and processes, providing troubleshooting and root cause analysis of non-conformances, low yields, or other quality/production issues
• Define, verify, and validate new manufacturing processes and design changes to existing products
• Develop and execute product/process testing protocols and document results
• Collaborate with quality and development engineering to create and ensure manufacturability of new medical device related products
• Develop and collaborate on the creation of automation, manufacturing fixtures, & equipment
• Develop and execute equipment qualifications (IQ/OQ)
• Contribute to development and execution of process validation activities
• Identify and implement areas of continuous improvement for current product production
• Train and/or provide work direction to manufacturing operators and technicians
• Provide product specific technical support as needed
• Work with vendors/suppliers on technical design, procurement, and fabrication of materials, equipment, fixturing, etc.
• Lead and/or support projects or project teams, as needed
• Understand and comply with ISO 13485, FDA, and CE requirements
• Generate and maintain all aspects of design history records per the Fiagon Quality Management System for all engineering-based activities related to new and existing products

• Bachelor’s degree in Mechanical Engineering or related discipline
• Prior experience with medical device product manufacturing and development. Balloon catheter development and balloon molding development is a plus.
• Ability to work in a fast-paced, dynamic work environment with a focus on technical excellence, responsiveness to customer needs and innovative thinking is required
• Mechanical aptitude with the ability to understand and optimize manufacturing processes
• Strong technical writing skills:
  Ability to write protocols, reports, manufacturing procedures, and supporting documentation.
• Hands on experience with fabrication of assembly fixtures, equipment, and test samples
• CAD experience, creation of parts and engineering spec prints
• Demonstrated knowledge of developing products within the framework of a QMS
• Critical thinking skills with the ability to solve problems and explain solutions
• Ability to manage multi