SENIOR STAFF ENGINEER - PROJECT MANAGEMENT
Diabetes Care, a business unit of the BD Medical Segment, is currently renewing its strategy for growth and is bringing in key talent in several functions. The growth strategy includes strengthening our core diabetes drug delivery devices as well as enabling expansion of our diabetes care portfolio. The Diabetes Care business unit has a long history within BD and is unique in that it focuses on one important disease state which is a threat to world health. The business unit is comprised of approximately 2,300 associates globally and the R&D team consists of approximately thirty individuals. If you are interested in being part of a dynamic organization that is building capability while focusing on important business goals read on.
The Senior Staff Engineer - Project Management reports to the Director of Research and Development in Diabetes Care. The Senior Staff Engineer will bring advanced engineering skills and leadership skills to R&D activities related to single use disposable products. The candidate will play a lead role in managing and leading the product development activities for DC products. The candidate will play the lead role in managing a cross functional team in designing of single use plastic injection products for diabetes therapy. This candidate must have strong engineering design background in high volume disposables, with expertise in design for manufacturing. This candidate must have proven experience in bringing new products to market in a structured enviorment for product development such as stage gate process. This candidate must be able to collaborate with all the cross functional team and be able to influence the members of the team towards the common goal. This candidate must have strong experience in managing budgets and timelines. This candidate must be able to work with manufacturing to ensure the design solutions are viable to be produced at high volume. This candidate will lead the overall assement of the tolerance anaylsis of the sub components. Identify new processes or new trends with single use disposable manufacturing for molding and maintain an overview of relevant technologies and products. Ensure compliance with BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures. Candidates should be prepared to present previous product engineering work during the interview process to demonstrate their abilities and experience.//
Duties and Responsibilities
* The Senior Staff Engineer’s primary role would be to lead a core team for the next generation DC products.
* The candidate will lead a cross functional team of experts to develop and launch the single use disposable products. The candidate will be responsible for identifying, developing and delivering innovative and practical solutions in alignment with the product development road map.
* The candidate will lead the cross functional team in the next generation injection systems by understanding the customer needs and translating them into functional engineering solutions to design safe and effective single use disposable products for injection.
* The candidate will maintain the yearly budgets and timelines on an ongoing basis and report periodically to the leadership team.
* The Senior Staff engineer will lead the efforts with the group in creation of specifications, design, and test methods for the new products.
* The Senior Staff Engineer would interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.
* The Senior Staff Engineer will be responsible for all phase gate related activities.
* The Senior Staff Engineer would interface with the manufacturing associates on a frequent basis to provide technical guidance on issues that arise where the issues impact form/fit/function of the product.
Additional responsibilities of this position are
* Identify and analyze design problems to achieve optimal solutions that satisfy cost targets, technical and functional requirements using both internal and external resources.
* Create and communicate project plans, task and deliverables and manage time to meet project deadlines.
* Lead the mold flow analysis of plastic components in the design phase to ensure mold ability of components.
* Lead the assesment of specifications on single use disposable products to develop correlation with functioinal requirements.
* Support manufacturing with new designs that will improve the process capability in manufacturing.
** Technology transfer: Participate in implementation of transition from research to development to manufacturing.
* Develop test methods to evaluate the functional requirements that are suitable in a high volume manufacutring environment and to meet the ISO and other requirements.
* Working with manufacturing and procurement identify alternate materials that will meet the quality and functiional requirements to reduce raw material cost for current products.
* Provide hands on support to all product engineering products.
* Plan, implement, monitor and deliver designated tasks and deliverables. Responsible for solving technical problems. Accountable for success of assigned tasks and deliverables.
** Budgeting: Provide input in developing project budget.
** Process effectiveness: Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities.
** Innovation: Develop creative and novel solutions to technical problems.
** Customer focus: Develop understanding of customer needs and processes to ensure relevant and innovative product development solutions.
** Continuous learning: Actively seek training to improve skills. Ensure technical lessons are reviewed, learned, and disseminated. Actively teach and promote learning.
* Must have a Master’s degree in a technical field preferably in Mechanical Engineering with at least 12 years of working in a medical device industry with proven record for launching products.
* Must have a strong leadership skills to lead a cross functional technical team of associates.
* Must have strong design skills in single use disposable products with experience in using SOLIDWORKS, and ProE.
* Must have at least 5 years working experience in plastics/polymers used in medical device industry with preferable specialization in single use disposable devices
* Must have a Six Sigma background in Design Methodologies for medical device components.
* Must have strong project management and budgeting background in R&D or manufacturing environment
* Must have a strong background in tolerance analysis of plastic components in molding and assembly
* Strong analytical and problem solving skills, as well as a good background in product development/manufacturing process specifically in high volume molding operations
* Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
* Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
* Experience in fixture creation & development and test method development, implementation and validation for medical device/system
* Highly desirable to have experience in mechanical test systems such as Instron for measuring forces, speed, and pressure
* Solid understanding of statistical concepts such as in measurement system analysis and validation
* Must have hands on experience in assembling prototypes and bench top systems for test equipments.
· Proficient in Microsoft office products with emphasis on Excel, and Word.
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**Job:** **New Product Development**
**Title:** **Senior Staff Engineer - Project Management**
**Location:** **New Jersey-Franklin Lakes**
**Requisition ID:** **NEW1001T*