Senior Engineer - Devices - Lupin Pharmaceuticals Inc.

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

• Design and development of drug combination products using mix of engineering principles, analytical, and experimental methods
• Identify the best tools and approaches to effectively solve engineering problems.
• To develop, optimize and/or analyze designs by applying the appropriate.
• Must have good knowledge of manufacturing principles as well as geometric dimensioning and tolerance tools.
• Must demonstrate knowledge of US regulatory and quality requirements such as 21CFR820.30
• Support documentation activities for MDR device registration in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing products in the most efficient and compliant manner
• Creates and updates technical documentation to achieve and maintain MDR certification
• Assists regulatory affairs in the preparation and submission of new products for the EU market
• Determines the regulatory impact of proposed product changes on EU registrations
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific accuracy, and clarity of presentation
• Support execution of technical and/or cross-functional project work.
• Implement test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.
• Ensure compliance with Lupin quality policies, standard operating procedures and practices

Desired Qualifications:

• BS degree in Engineering (Mechanical Engineering, Biomedical Engineering or a closely related engineering degree required).
• Minimum of 4 years of engineering experience or equivalent and compiling documentation for US FDA submission and EU MDR is required
• Demonstrated accountability for successful completion of designated tasks.
• Understanding of disciplined product development processes and quality requirements.

Lupin  is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

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