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

Position Requirements:

·         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