Open Positions

Sonitus Medical is currently recruiting for the following positions:

Quality Assurance Manager

Reports to: Director of RA/QA

Major Duties and Responsibilities:

Oversee and develop various quality system elements such as Document Control, CAPA, NCMRs, Audits, and Training.
Conduct CAPA investigations and write final reports
Manage the effective operation of the document control system and maintenance of the relevant records
Perform internal audits
Track and trend quality objectives and present to executive management.
Support management review process
Participate in regulatory audits of quality systems.
Ensure company and products are compliant with applicable regulations and laws
Manage documentation and promote good document practices in compliance with 21 part 820, ISO:13485, EU Medical Device Directive(s), and any other pertinent country specific medical device regulatory requirements
Coordinate and/or assist in preparation of regulatory approval applications and Technical Files
Implement changes to quality system documents such as SOP's, WI's, and other operational documents.

Education / Qualification Requirements:

BS/BA degree in science or technical discipline (or equivalent) is required. A degree in engineering is preferred.

Skills / Experience:

Broad-based Quality experience with medical devices and a minimum of seven years related experience in the medical device industry
Demonstrated knowledge of statistics and data analysis is preferred.
A good understanding and demonstrated competence in relevant quality standards, such as ISO 13485, Medical Device Directives, and FDA 21 CFR Part 820 required.
Experience in hearing aids or other similar acoustic devices or miniaturized electronic medical devices is desirable.
Excellent verbal and written communications skills are required.
Proficiency in the use of Excel, Word, and PowerPoint is required.
Previous experience managing projects and the ability to drive to timely completion is preferred.
Must have the ability to effectively multi-task and prioritize activities.
Experience interfacing with Regulatory Auditors is preferred.

Sr. Quality Engineer

Reports to: Director of RA/QA

Major Duties and Responsibilities:

Manage complaint process; drive investigations and address failure root causes. Assess the reportability of complaints to regulatory agencies.
Support quality control activities, including, but not limited to: IQC, in-process and finished product testing and release, Risk Management activities (FMEA, hazard analysis), IQ/OQ/PQ, etc.
Coordinate with manufacturing, purchasing, and receiving to ensure proper prioritization of inspection tasks
Provides site metrics for various quality system elements and present to executive management.
Work with cross-functional teams during product development process (design control)
Qualify suppliers and conduct supplier audits.
Write, review and approve validation documents related to product, processes, facilities and equipment.
Participate in regulatory audits of quality systems including internal audits.
Implement changes to quality system documents such as SOP's, WI's, and other operational documents.
Perform other duties as assigned

Education / Qualification Requirements:

BS/BA degree in science or technical discipline (or equivalent) is required. A degree in engineering is preferred.

Skills / Experience:

A minimum of 5 years of direct medical device experience in Quality Assurance or an equivalent field is required.
Demonstrated knowledge of statistics and data analysis is preferred.
A good understanding and demonstrated competence in relevant quality standards, such as ISO 13485, Medical Device Directives, and FDA 21 CFR Part 820 required.
Previous experience in complaint handling desired.
Experience in hearing aids or other similar acoustic devices or miniaturized electronic medical devices is desirable.
Experience in product development and manufacturing is preferred.
Excellent verbal and written communications skills are required.
Proficiency in the use of Excel, Word, and PowerPoint is required.
Previous experience managing projects and the ability to drive to timely completion is preferred.
Must have the ability to effectively multi-task and prioritize activities.
Experience interfacing with Regulatory Auditors is preferred.

Dental Technician

The Dental Technician will construct and repair dental appliances. The primary duties will be to pour dental models from dental impressions, fabricate dental appliances, and prototype oral appliances for novel sound transmission devices.

Qualified candidates will have a HS diploma (dental certification a plus), and have skills which include bending wires, fabricating clear and Hawley retainers and splints. Must possess knowledge of different dental materials and have a minimum of 1 year of experience in a dental laboratory environment. Must be a positive, self-confident, and creative individual with good communication skills. Good computer skills is a plus.

Customer Advocate

The Customer Service Advocate will be the initial point of contact for patients, providers, and SoundBite Consultants. The primary responsibilities will be to complete benefit investigative services, conduct inside sales, and provide order entry management, customer service and technical and sales support. This position will diagnose, troubleshoot and process all field issues reported. Will create and maintain customer replacement and site orders via the RMA process, ensure compliance with company and FDA regulations and policies, and professionally and effectively communicate with all related departments and customers. The Customer Service Advocate will respond to all web inquiries in a timely fashion, back up other customer support functions, and assist with special projects, as needed. This position will easily adapt to functional company databases and systems and multi-task between them effectively.

Qualified candidates will have prior experience in a customer service and sales support function in a consumer healthcare medical device environment. Healthcare reimbursement service experience is a plus. Must have a commitment to excellence and the ability to provide excellent service to all customers, internal and external. Must be highly efficient at following instructions and recognizing areas of improvement. Acute attention to detail, strong interpersonal skills; ability to deal with a diversity of individuals at all organizational levels is required. The ideal candidate will enthusiastically adapt to frequently changing processes and procedures and have a proficient understanding and adaption of CRM/ERP systems (experience with SalesForce.com is an advantage). Must have the ability to perform diverse administrative functions, possess excellent written and oral communication skills, and be compliant with all company FDA, ISO, and HIPAA regulations and requirements.

Reimbursement Coordinator (temporary)

The Reimbursement Coordinator will provide accounts receivable support to the reimbursement department. This position will deal with patients to resolve accounts receivable discrepancies or to answer other related inquiries. Will post collections in two computer systems and reconcile accounts. Send out outstanding billing statements to patients and follow up with collections calls. This position will set up payment plans and review them on a daily basis with management, balance accounts receivable reports with regards to outstanding vs. paid invoices, and follow up with insurance companies on outstanding or underpaid claims. Will respond to requests for information from insurance companies and complete additional tasks, as needed, to assist the reimbursement and accounting departments.

Qualified candidates will have at least a HS diploma, and a minimum of 5 years of medical billing and A/R experience. Must have working knowledge of desktop computer software.

Principal Mechanical Engineer

The Principal Mechanical Engineer will support the development of Sonitus Medical's current and next generation hearing and communication platforms through R&D, clinical evaluations/testing & integration into manufacturing.

Responsibilities will include the following:

Support ongoing product development & sustaining efforts related to the company's SoundBite Hearing system.
Mechanical design & development of next generation hearing and communications platform & accessories, including human factors analysis, modeling & prototyping of alternate mechanical form factor, packaging design, materials research & development, investigation into improved/automated assembly techniques
Perform finite element modeling & analysis as necessary to ensure designs are robust.
Conduct & document experiments, such as reliability & fatigue testing.
Work with manufacturing/process engineering to design & develop custom assembly & test fixtures to support production.
Work closely with vendors to ensure parts are manufacturable & meet design requirements.
Work with marketing & clinical teams to ensure designs meet user requirements for form, fit & function.
Provide appropriate testing & documentation to support regulatory filings.

Requirements include a BS in Mechanical Engineering (preferred) or related discipline, with solid fundamentals in materials science. 5+ years in product development environment, preferably medical devices. Creative, motivated individual with an excellent work ethic and the passion to succeed. Substantial design experience with SolidWorks, Pro-Engineer or similar 3D CAD packages. Experience with product integration into mfg. preferred. Experience with plastic part injection molding design preferred. Excellent analytical, communication & organizational skills; able to present work to non-technical audience. Familiarity with ISO requirements, GMP guidelines, FDA regulations & medical device design controls a plus. Experience in a start-up environment a plus.

Interested candidates can submit their résumés to hr@sonitusmedical.com. No telephone inquires, please.

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