Job Summary:

This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.

Area Of Responsibility:

Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements
Prepare 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
Perform and complete mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate
Participate in project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects
Ensure 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
Contribute to new and supplemental regulatory submissions
Train and/or provide direction to technicians; may train manufacturing personnel and/or suppliers when required
Contribute ideas or generate Intellectual Property submissions
Other duties as assigned

Performs all principle 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.

Work Conditions:

Office
Lab
Manufacturing area/clean room area
Maintenance Shop
Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell
Close, distance and peripheral vision; depth perception, ability to focus
Ability to operate production equipment and hand tools
Operate hand truck
Operate computer/office equipment
Wear proper lab gowning and safety shoes
Lifting and moving of heavy boxes/equipment up to 70 lbs.

Travel Estimate:

Up to 10%

Education and Job Qualification:

BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered
Ability to interpret and resolve technical and design issues required

Experience:

7 years of experience in the medical device industry and/or biomedical field preferred
Familiar with QSR / GMP regulations
Experience with Microsoft Office Tools and Solid Works required
Pharmaceutical industry experience a plus

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).

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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