Validation Engineer

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 Validation Engineer (VE) will work cross-functionally within the organization and has a background in medical device manufacturing. The VE will be responsible for the writing and execution of validation protocols. They should have experience with both test method validation and process validations. They will be responsible for identifying gap assessments within older validations and remediating those to be compliant with new company and ISO standards. The VE is responsible for writing validation protocols and reports. The VE should be comfortable working in a fast-paced environment and be willing to help where needed, including updating and filing specification and design documents, risk documents, and ECNs.

Duties and Responsibilities:

Responsible for the execution or review of required validation activities supporting company initiatives

Validate current and new products and processes

Perform validation remediation as required

Provide periodic updates of assigned validations and communicate identified roadblocks to CFT

Participate in site validation strategy

Develop, update, and maintain site validation procedures and related records

Perform data integrity verification on assigned validation documents

Review and approve assigned validation documents with CFT

Assess operational control via audits

Draft appropriate documents to support the Quality Management System. Support the document control and project management systems

Support research and development by updating and filing specification and design documents as well as ECNs

Perform all duties required for compliance with validation -related corporate systems

Make decisions on product/process quality based on valuations

All other duties, as assigned

Qualifications/Specifications:

Bachelor’s Degree in Engineering or equivalent

Basic knowledge of statistics and quality engineering techniques

Experience in validations, including but not limited to product, process, equipment, test methods, DOE, cleaning, sterile product and software validations

Experience with medical device design and development, preferred

Knowledge of FDA regulations, Medical Device Directive 93/42/EEC, and ISO Standards

Strong technical writing skills for protocol and report generation

Attention to detail

Strong communication skills (written and verbal)

Experience in process improvement and automation

Good Documentation Practices and Good Manufacturing Practices Experience, required

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