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Vice President of Sales

Company: MCI
Location: Billerica
Posted on: September 13, 2020

Job Description:

Senior Associate, Product Engineering, DUSA Medical Devices, A Sun Pharma Company

JOB SUMMARY:

This position will provide mechanical and electro-mechanical engineering for sustaining engineering support for existing medical products as well as new projects. The ideal candidate will have experience in the biomedical field. Must additionally have the ability to interpret and resolve technical and design issues.

ESSENTIAL FUNCTIONS:

Provides support for existing products, product investigations and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements

Prepares and maintain all necessary product documentation including product specifications, bills of material, hazard / risk analysis, test procedures, and associated validations and procedures and support of suppliers and contract manufacturers

Performs and completes mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate

Participates in project teams and assists with project plan definition, estimation, scheduling, tracking, and reporting for related projects

Ensures that all aspects of the quality system are a high priority in all activities (e.g., design and development activity, validation protocols, risk assessment, etc)

Develop specifications, packaging, labeling and all associated design control documents in accordance with project, industry and regulatory requirements

Contributes to new and supplemental regulatory submissions

Trains and/or provides direction to technicians ; may train manufacturing personnel and /or suppliers when required

Contributes ideas to or generates Intellectual Property submissions

Performs all principal duties that affect the quality of products and services provided by DUSA Pharmaceuticals, Inc. within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business

EDUCATION AND EXPERIENCE:

BS/Mechanical Engineering with 3+ years of experience in the medical device industry preferred.

Associates in Mechanical Engineering or relevant experience will be considered .

Familiar with QSR / GMP regulations.

Microsoft Office Tools and Solid Works is required.

Pharmaceutical industry experience a plus.

10% domestic travel may be required.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Keywords: MCI, Billerica , Vice President of Sales, Other , Billerica, Massachusetts

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