Manufacturing and 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 and Process Development Engineer to support our increasing demand and implementation of new medical device products to market.

The qualified candidate will provide a role in developing new product & manufacturing processes as well as 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.

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:

• Define, verify, and validate new manufacturing processes and design changes to existing products
• Perform engineering and quality analysis of processes
• Develop and execute product/process testing protocols and document results
• Collaborate with quality and development engineering to 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
• Provide product specific technical support as needed
• 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 multiple tasks simultaneously, establishing project plans, achieve timelines, and communicating results
• Strong organizational skills and attention to detail
• Excellent written and oral communication skills

Hemostasis believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives.

Hemostasis believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives.