Sustaining Engineer III

Indianapolis, IN

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Summary:

The Sustaining Engineer III is responsible for addressing sustaining engineering related issues identified by R&D, Manufacturing and Service Engineering. The Sustaining Engineer III will assist in securing and maintaining compliance to international standards for company products.

Duties and Responsibilities:

Initiate and manage projects related to securing compliance with international standards required for USA and international regulatory compliance.

Work with third party test facilities to organize and execute the testing of products for compliance with standards.

Work with R&D, Manufacturing, Regulatory Affairs and Quality Assurance to address compliance with new standards required to maintain regulatory approvals.

Develop appropriate project communication plans and effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.

Estimate the resources and cross-functional participants needed to achieve product compliance and sustaining engineering project goals.

Initiate and manage projects related to product support.

Prioritize engineering change notices (ECN) to address manufacturing and service needs.

Work with Quality Assurance to provide engineering support to address Non-conforming Material disposition, CAPA and Correction related activities.

Provide engineering support to Manufacturing and Service to address issues relating to manufactured products.

Develop departmental procedures to address ECN and other manufacturing and service support related activities.

Participate in new product development design and test activities for compliance to international standards and addressing design considerations for future product support.

Document and maintain design history file and technical file as required by USA and international regulatory requirements.

All other duties, as assigned.

Qualifications/Specifications:

Bachelor’s or Master’s degree in engineering or related field or equivalent experience, electrical/electronics engineering background preferred.

5 years of experience in the medical device industry developing imaging devices, product design, mechanical engineering, electrical engineering, and/or ultrasound systems.

Demonstrated experience in the areas of securing compliance to international standards for CE marking.

Familiarity with FDA Quality System Regulation and ISO 13485 medical device regulatory requirements. 

Experience in hardware, software interfacing, electromechanical systems, circuit board layout/design, metals, and manufacturing methods and processes.

Demonstrated experience in troubleshooting problems encountered during manufacturing and service of medical devices, including hands-on experience with oscilloscopes, spectrum analyzers, measurement systems.

High level of ethics and credibility, goal-oriented and reliable

Understanding of product development within an ISO/ Quality System framework or an environment related to medical devices.

Good communication skills: written/ oral.

Familiar in the operation and or theory of ultrasound imaging and therapy devices, preferred.

 

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