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:

This position is primarily responsible for creating and revising technical documents, and investigations associated with Manufacturing Process Instructions (MPI’s), non-conforming product or materials (NCR’s). This position is expected to work with and assist manufacturing engineers and quality engineers in resolving issues in manufacturing. It is also expected that in this position there will continue to build their skills by undertaking tasks and direction from the engineering departments.

Key Responsibilities:

• Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are controlled according to the Quality System.
• Writes and edits technical documents including reference manuals and product manuals.
• Ability to translate customers technical specifications into work instructions for the direct labor staff that will enable them to follow with little to no training.
• Writes and edits procedural documentation such as user guides and manuals.
• Dispositions Non-Conformance Reports (NCR”s) and routes Engineering Change Request (ECN’s)

Must Have:

• 3 Plus years’ experience in the engineering/manufacturing environment for medical devices.
• 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
  

Good to have:

• Associate degree or equivalent
• Green Belt or Black Belt

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.