IngMar Medical (www.ingmarmed.com) is the worldwide industry leader in respiratory simulation.  Our unique breathing simulators and test lungs are used to: develop groundbreaking products and treatments; test for quality and safety; and, train healthcare professionals. Established in 1993, IngMar Medical has experienced steady growth in product offerings and sales. We are currently in the process of doubling the size of our facility to provide additional space for our Engineering and Production departments. Simulation training, long established in fields such as aviation and the military, is now rapidly being integrated into the field of healthcare, offering a favorable climate for our company’s future growth.

IngMar Medical is conveniently located in the East End of Pittsburgh, close to Whole Foods, Target, and Bakery Square.

We have an opportunity for an experienced quality engineer to lead the design and implementation of a Total Quality Management System. You will play a key role in product development, production engineering, and overall quality improvements. In the collaborative entrepreneurial environment of IngMar Medical, you will be a valued expert empowered to make and implement decisions (a big fish in a small pond).

Responsibilities

• Develop, communicate, implement, and maintain a Total Quality Management System including a formal Quality Manual
• Provide Quality Engineering support to Production, R&D, and other areas to ensure that products are designed and manufactured with the high level of quality required by our customers (which include medical device manufacturers regulated by the FDA)
• Prepare company for ISO/IEC17025 certification for testing and calibration laboratories and, subsequently, ISO 9001 Certification
• Create, document, and implement inspection criteria and procedures throughout the production cycle 
• Interact with vendors to ensure quality of incoming components
• Provide guidance and leadership to solve process and product issues with the help of Marketing, Sales, and customer feedback
• Develop verification and validation procedures for software and hardware products
• Drive continuous improvement efforts with practical solutions. Simplify processes using realistic practices

Requirements

• BS in Electrical/Mechanical Engineering or equivalent work experience
• Minimum 5 years of experience preferably within the medical device manufacturing industry:
• Applying quality assurance and control tools (statistical analysis)
• Developing quality process and validation methodologies
• Working directly with suppliers and manufacturing
• Basic understanding of C, C++ programming languages; knowledge of LabVIEW a plus
• Strong communicator with proven ability to develop and maintain relationships with internal and external contacts – a team player!
• Drive to succeed, strong initiative and entrepreneurial spirit
• Competitive salary and generous benefits package including health insurance, long-term disability insurance, 401(K) plan, 15 days paid vacation, and 6 paid sick/personal days.

Please email resume and cover letter to: David Rea drea@catalystconnection.org