Process Development Technician II

About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team.

About the role

The Process Development Technician II is primarily responsible for providing tools and support to engineering and production while adhering to the quality and cost requirements of the company. The tools include but are not limited to written processes and procedures, equipment, fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support other engineers and areas as needed and performs at an advanced level.

Responsibilities

• Identifies, executes, and promotes Continuous Improvement objectives
• Assists in defining Lean Manufacturing requirements
• Develop processes and procedures for projects to improve quality and cost
• Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
• Represent engineering for Material Review Board concerning material dispositions
• Represent Engineering in cross functional teams as assigned
• Maintain compliance to procedures and regulatory requirements
• Understand and follow safety policies and practices, attend safety training and wear PPE as required
• Maintains and prepares project plans to satisfy timeline requirements
• Prepares Engineering Change Orders for processes and components
• Performs Corrective and Preventative Action tasks

Requirements

• High school diploma or GED
• 3+ years’ experience in the engineering/manufacturing environment for medical devices
• Knowledge of FDA, cGMP principles and practices (ISO 9001, ISO 13485)
• Strong computer skills associated with Microsoft software
• Ability to interpret technical drawing, blueprints, specification, and illustrations
• Prior process development experience in a medical device environment
• Must be able to read, write and speak fluent English
• Excellent reading, writing, communication, and organizational skills
• Demonstrated ability for systematic problem solving, DMAIC

Skills

• Experience with Silicone molding is a plus
• Familiarity with Pro-E / CREO and/or SolidWorks is preferred

Pay

$31.95 to $35.00 per hour

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match