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 developing and improving assembly operations in an effort to improve productivity, yield and process flow. Must provide excellent trouble shooting ability on equipment and assembly fixturing. Assist Manufacturing Engineering to develop new processes, documentation, perform experiments and develop tooling/fixturing as needed.
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
- Works with engineers, programmers, and project managers to ensure safe reliable delivery of final product to the customer
- Research new processes and equipment that improves line efficiency
- Ability to meet internal and external customer deadlines
- Works with Engineering, customer representatives and manufacturing personnel in problem solving exercises.
- Work with Maintenance personnel to incorporate equipment PMs
- Working knowledge of drawings with ability to interpret nomenclature and dimensions
- Operates effectively and maintains professionalism in an environment of deadlines and high workloads and adjusts schedule or work hours to meet changes in priorities
- Assists with processes and documentation for new or modified products
- Active participation in improving quality and processes for the products we manufacture.
- Acts as a resource during audits or customer visits for questions and answers or practical demonstrations
- Supporting required equipment qualification and process validations (IQ, OQ and PQ).
- Be a key trainer for employees on new processes and products being transferred from Engineering to Production.
- Assist engineering in improving quality and solving problems.
- Design fixtures and gauges.
- Process basic ECO's to existing drawings, tooling and fixtures.
- Dispositions Non-Conformance Reports (NCR's)
Must Have:
- 2+ years of engineering technical experience in a medical manufacturing environment, or equivalent
- Hands on experience working with equipment
- Advanced equipment trouble shooting experience
- Knowledge of manufacturing and assembly processes
- Excellent verbal and written communication skills
- Must be able to read, write and speak fluent English
- Excellent organizational skills and attention to detail
- Ability to meet deadlines and to work independently
- Experience with continuous improvement activities
- Proficient with Microsoft Office Suite or related software
- Basic understanding of Lean Concepts
- Ability to learn and apply new technology
- Able to prioritize and manage multiple responsibilities
- Basic working knowledge of blueprint and geometric tolerances
- Ability to diagnose and solve problems with jobs in a timely manner
- Validation experience
- Technical report preparation experience
Good to have:
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.
Cirtec Medical
paid time off, 401(k)
Nov 22, 2024