The Engineer must perform electro-mechanical design and development functions for Class I and Class 2 medical devices throughout the entire product lifecycle in accordance with established design control and risk management procedures, design and execute verification and validation plans, execute engineering change orders, and develop and maintain risk management and design history files. This position is located in Warminster, PA and pays $85k/year.

Essential Functions:

·         Implementation of design control and risk management procedures.

·       Work with cross functional team (CFT) to develop design and development plans, verification and validation plans, and risk management plans.

·         Work with CFT to define and/or review requirements and design specifications.

·       Plan and execute design verification and validation (V&V) testing of medical devices and their sub-systems.

·         Conduct design review meetings.

·         Develop and maintain risk management files (RMF) and design history files (DHF).

·         Facilitate the execution of design changes and engineering change orders (ECO).

·         Perform other duties and tasks as assigned by their supervisor/manager.

·         Strong interpersonal and communicative skills.

·         Strong problem solving skills.

·         Knowledge of washer/disinfector design is an advantage.

·         Project management skills and experience is an advantage.

Education Required:

Must have a BS and 3 years’ experience in a related engineering field, an AS and 5 years’ experience in a related engineering field, or 7 years’ of practical experience in a related engineering field.

Practical Experience:

Proficient in the use of computer aided design programs, Microsoft Word and Excel knowledge required.

Basic understanding of computer operating system, file structure, network setup, etc. required.