Staff Engineer - Devices

Overview

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.

Responsibilities

• Design and development of drug combination products (inhalation and injectables) by understanding design space and managing critical design parameters.
• Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to solve complex engineering problems. Solidworks experience is required.
• Using design for manufacturing principles as well as geometric dimensioning and tolerance tools to create sound engineering drawings.
• Identify the best tools and approaches to effectively solve engineering problems.
• To develop, optimize and analyze designs by applying the appropriate mix of engineering principles, analytical, and experimental methods.
• Support the evaluation and assessment of new technologies, intellectual property, products, and processes
• Support current products in terms of quality, manufacturing, and cost improvement.
• Support execution of technical and cross-functional project work.
• Write detailed technical reports based on design verification testing for design changes and product design activities.
• Develop and implement detailed test methods
• Develop realistic and actionable design plans.
• Effectively collaborate with laboratory technicians and support staff.
• Ensure compliance with Lupin quality policies, standard operating procedures and practices
• Must have knowledge of and experience with Factory Acceptance Testing, Process Validation and IQ/OQ/PQ’s.
• Must demonstrate knowledge of US regulatory and quality requirements such as 21CFR820.30

Qualifications

Desired Qualifications:

• BS degree in Engineering (Mechanical Engineering, Biomedical Engineering or a closely related engineering degree required).
• A Master’s degree in engineering is preferred.
• Minimum of 8 years of engineering experience or equivalent is required with a strong preference for least 5 years in product development
• Strong interpersonal skills.
• Excellent technical judgment.
• 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.

Search Firm Representatives Please Read Carefully 

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails

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