Director of Engineering

Director of Engineering position for a manufacturer of medical instrumentation products.
Primary responsibilities will include:

• Direct and manage department activities to design new products, modify existing designs, improve production techniques, and develop test procedures. Resolves problems using solutions that involve new techniques, technologies, or concepts.


• Management of engineering group (electrical and mechanical) to assure optimal efficiency, timely response, and accuracy of group functions.


• Perform all aspects of systems engineering including: concept, architecture, block/functional diagrams, system level documentation, strong knowledge of electrical, software and mechanical engineering concepts.


• Wide salary range, depending on experience.

• BS or MS degree in engineering or related.


• Senior level engineering experience in manufacturing environment.


• Experience in medical devices or instrumentation would be best.


• SPECIAL REQUIREMENTS:


• ISO-13485, FDA, MDD and CSA requirements for engineering


• Knowledge of the following standards IEC 60601, IEC 61010


• Knowledge of Usability standards IEC 60601-1-6 and IEC 62366


• Knowledge of Risk Analysis Standard ISO 14971.


• Knowledge of EMC standards IEC 60601-1-2


• Knowledge of RoHS, and WEEE directives