Manufacturing Engineer

Job Description

Job Description

Hemostasis, LLC designs, develops, manufactures and markets advanced hemostat and wound healing technologies for use in the medical device industry. We are currently seeking a Manufacturing Process Engineer to add to our growing team. This role will interface in a collaborative team-based environment with the new product development, manufacturing, research, quality, regulatory, sales, and marketing teams to support and drive the successful implementation of new equipment and continuous improvement of existing products and processes.

The responsibilities of this position include:

• Define, verify, and validate new processes and modifications to existing products
• Perform engineering and quality analysis of processes and prototypes
• Develop and execute product/process testing protocols and document results
• Collaborate with manufacturing and engineering to ensure manufacturability and execution of fixture builds
• Collaborate with automation engineers on the design of assembly equipment
• Identify areas of improvement for current processes
• Provide product specific technical support as needed
• Lead 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 Hemostasis Quality Management System for all engineering-based activities relate to new and existing products

Position Requirements:

• Bachelor’s degree in Biomedical or Chemical Engineering
• 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
• Demonstrated knowledge and record 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 and achieving timelines and communicating results
• Demonstrate proactive and strategic thinking and be able to handle change and ambiguity
• Strong organizational skills and attention to detail
• Excellent written and oral communication skills

Hemostasis, LLC, believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement and related benefits.

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