Process Development Technician II

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

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 challenge, you may be a perfect fit for our team!

Position Summary:

The Technician II, Process Development 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 included but are not limited to written processes and procedures, equipment and 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.

Key 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

Reliable, consistent, and punctual attendance is an essential function of the job

* Other Duties as assigned.

Must Have:

Bachelor's degree in related technical field

* 3 Plus years' experience in the engineering/manufacturing environment for medical devices

* FDA, cGMP principles and practices, (ISO 9001, ISO 13485)

* Experience with Silicone molding is a plus

* Familiarity with Pro-E / CREO and or SolidWorks is preferred.

* Strong computer skills associated with Microsoft software

* Ability to interpret technical drawing, blueprints, specification, and illustrations

* Must be able to read, write and speak fluent English.

* Excellent reading, writing, communication, and organizational skills.

* Demonstrated ability for systematic problem solving, DMAIC

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.