BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit See below.
About us
Description
Lead an R & D team from the definition phase through global product launch of a game changing combination medical device.
Qualifications
Masters in Mechanical Engineering/Chemical Engineering/Pharmaceutical Engineering or related field with at least 5 years of relevant experience, and/or PhD degree with at least 3 years of experience.
* Minimum of 5 years experience (for MS) or 3 years experience (for PhD) in the medical device industry in R&D. * Demonstrated ability to lead a technical team in the development and commercialization of a medical device through a Pre-Market Approval (PMA) regulatory pathway, including translation of customer requirements into product requirements and specifications for a combination drug-device. * Demonstrated ability to provide all necessary experimental design, testing, product development and transfer to large scale manufacturing for a combination drug-device.
Skills
• Excellent interpersonal, communication and influencing skills
• Strong technical judgment
• Experienced in project planning
• Demonstrated leadership.
• Understanding of disciplined product development processes, regulatory and quality requirements
• Results driven and action oriented
Understanding of and experience with, pharmaceutical test method development for safety, efficacy and
stability.
Ability to develop and validate test methods
Effectively lead and direct the work of other engineers and laboratory technicians to achieve objectives
* Identify, break down and solve complex problems, and provide technical direction to others * Independently plan and execute to achieve design and development objectives * Set priorities for self and team * Participate as a member of a cross-functional team or lead a cross-functional team to deliver to business-critical product development commitments * Using expert technical skills, conceive, plan and lead development activities from concept through successful commercialization * Leverage understanding of first engineering principles, advanced engineering methods, data and judgment to influence the course of product development activities * Participate in implementation of technology transfer from research to development to manufacturing. * Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities. * Develop understanding of customer needs and processes to ensure relevant and innovative product development solutions. * Actively seek training to improve skills. Ensure technical lessons are reviewed, learned, and disseminated. Actively teach and promote learning. * Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures. * Team leader with proven ability to deliver results. * Knowledge of pharmaceutical stability and packaging. * Experience with combination drug-device manufacture. * Ability to plan multiple work-flows and identify ways to optimize time lines and reduce technical development risk. * Ability to reduce complex technical requirements and analysis into easy to understand language and communicate effectively to a cross-functional team.
Passion for leading technical product development, commercialization and launch.
Job Mechanical Engineering
Primary Location US-New Jersey-Franklin Lakes
Shift First Shift / Day Job
Relocation Available Yes
Nearest Major Market: New Jersey Job Category: Engineering, Scientific, Engineer, Chemical Research, Manufacturing Engineer, Chemical Engineer, Mechanical Engineer, Medical Device Engineer, R&D Engineer, Research Engineer, Healthcare, Medical Research, Medical Device, Medical Technology, Legal, Law, Compliance, Research, R&D, Research, Product Development, Science, Laboratory
