what in All Locations Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming       PRINCIPAL ENGINEER Job Company - Bristol-Myers Squibb Location -  New Brunswick, New Jersey  US   Job Code - 38732 Position - Job First Active on: Friday, January 27, 2012 PRINCIPAL ENGINEER •Lead cross-functional device development projects from concept through commercialization. Responsibilities include the selection, development, commercialization support, and lifecycle management of drug delivery devices for various drugs within BMS pipeline. •Project leadership activities include driving the establishment and validation of user requirements, translation into product/engineering specifications, design verification and validation activities, design reviews, design transfer and process validation activities, risk assessments, as well as post-market assessment activities leading to identification and implementation of potential product design improvements. •Identify new technologies for drug delivery and leverage understanding of first engineering principles, customer needs, and technical judgment to assess device platforms against internal and external needs, with emphasis on safety, efficacy, user convenience, design robustness, manufacturability, and other BMS business objectives. •Vendor selection and management - Identify best-in-class industry partners to establish business relationships and leverage existing technologies to develop innovative and differentiated delivery device platforms, balancing internal versus external investment and development activities. Responsibilities include collaborating with Global Procurement and Legal to ensure robust and favorable contract terms for partnership activities. •Maintain an overview of state-of-the art technology development within drug delivery by identifying trends in clinical practice and regulatory landscape, evaluating and benchmarking competitive products, processes or new trends which may impact BMS business. Develop and maintain a network of professionals/experts to advance BMS goals and be at the forefront of technology development and innovation. •Use advanced engineering skills to design experiments using DOE methodology and analyze the test results using statistical tools. Lead efforts in creating and developing methods and test stations for characterization, experimenting and testing components, delivery devices and systems. •Ensure all development activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities. •Responsibilities also include mentoring and developing other members of the Device Operations team. REQUIREMENTS - QUALIFICATIONS: PRINCIPAL ENGINEER •BS degree in Mechanical Engineering or relevant engineering discipline. Advanced degree a plus. •Minimum of 10 years of device development (from concept through commercialization) experience in the Medical Device, Pharmaceutical or Biotechnology industry for combination products •Broad and deep understanding of disciplined product development process, including design controls, design transfer, validations, and regulatory submission process •Strong cross-functional perspective, leadership and influencing capabilities within a matrix organization •Strong written and verbal communication skills, with special emphasis on technical writing for regulatory filings •Strong technical skills and familiarity with competitive landscape, industry trends, and regulatory environment for combination products. Bristol-Myers Squibb Apply to this job! View Company Jobs Free Career Test Your Resume on 75 Job Sites

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