Senior Associate, Product Engineering, DUSA Medical Devices, A
Sun Pharma Company
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.
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
Participates in project teams and assists with project plan
definition, estimation, scheduling, tracking, and reporting for
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
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
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).