Design Assurance Engineer

Design Assurance Engineer

 

The successful candidate will perform Design Assurance engineering work requiring full competency in all conventional aspects of Bio-Medical Engineering and the Control and Review of new product designs.

 

We are a fast growing company developing wireless medical systems.  With a hardworking but informal culture. Along with our outstanding growth opportunities, we offer competitive salaries and benefits, tuition reimbursement, and stock plan.  Cleveland Medical Devices is an Inc 500 company, an Inc Inner City 100 Company (three times), and a Weatherhead 100 award winner (four times).  Please visit us at www.CleveMed.com   If you desire to advance your career by pushing the state-of-the-art in wireless design, please send resume (e-mail in Word format with references and salary history) to: recruiter@clevemed.com

 

Primary Job Responsibilities:

 Manage Qualification (EMC, Safety and functional) test processes for system and sub assembly testing of medical products. Coordinate clinical validation and qualification testing of new products, accessories and components. Assist development engineers in establishing reliability test techniques and test structure design for new and emerging technologies Prepare and set up programs for device test, measurements and experiments Build and modify test fixtures  Provide test data and reports to Quality and R&D staff Evaluate product quality/reliability problems and make decisions to adjust reliability standards or change processes as appropriate. Participates in all phases of the control and review of new product designs to assure:

·  That potential defects are eliminated at an early stage in the design process

·  That critical component and process capabilities are evaluated and included in the design process in order to assure the end result is a "robust" design, including reviewing designs for sources of potential failure and for manufacturability.

·  Quality Assurance- implementing and maintaining Design Control systems which comply with Corporate Policies, training staff and key personnel in order to attain strategic objectives. Establishing design control documentation required for compliance to applicable regulations and standards (e.g. 21 CFR Code of Federal Regulations 820, ISO 13485).

·  Participate in product and process risk assessment activities, including Hazards Analysis, and Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA) to ensure compliance to ISO 14971.

·  Conduct and lead design validation and process validation activities.

·  Performs other duties as assigned.

 Qualifications: Understand electrical circuitry and have basic understanding of mechanical engineering Possess skills to understand specification requirements and then translate these requirements into testing and related test procedures. A BS Degree Electrical, BioMedical, or Mechanical Engineering. 1 to 2 years experience with development and test of medical products. Desired basic understanding of FDA 21CFR 820, ISO 13485, ISO 14971, IE 60601 and Supplier Qualification requirementsDemonstrated experience in the use of common laboratory-type equipment. Strong analytical, problem-solving, leadership, verbal/written communication, technical writing, and multi-tasking skills. Ability to work well with others in various disciplines and at various sites. Ability to plan and conduct effective meetings and group presentations.