Advanced Manufacturing Engineer I

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Support new product team design activities including

- Provide concept development input
- Develop project plans and schedules
- Leading process reviews and assessing design for manufacturability

Plan, coordinate and manage all manufacturing activities associated with commercialization and launch of new products including:

- Concept and development of all methods and processes
- Coordination of all development and manufacturing of new tooling and equipment
- Coordination and support of all new vendor tooling
- Development and release of all product and process documentation including Process Specifications, Process Controls and PFMEAs
- Performing process characterization of all new operations and processes using design of experiments (DOE)
- Developing, executing, analyzing and writing reports for validation protocols
- Preparation of capital equipment requisitions

Plan, coordinate and manage all activities to transfer new products from design to manufacturing including:

- Development and management of a transition plan and team
- Process documentation transfer and review
- Facility selection, coordination & preparation
- Equipment moves and installation
- IQ, OQ, PQ protocol development and execution support
- Production startup and training support

Support sustaining manufacturing projects including

- Leading / supporting failure investigations
- Project planning and execution of small to medium scale projects
- Protocol generation (characterization through validation) and execution
- Change implementation planning (including coordinating quality and regulatory timing with cross functional team)

Responsibilities

The Advanced Manufacturing Engineer I (AMEI) will be primarily responsible for detailed project management, engineering support and direction for manufacturing activities to support the development and commercialization of new products.; In addition, this role may support sustaining engineering activities including capacity expansions and failure analysis on existing platform based products.

Requirements

BS degree in Engineering required (mechanical, chemical, biomedical or equivalent); AME I – BS degree with minimum 3 years experience or MS degree with minimum 2 years experience; Demonstrated proficiency in equipment and tooling procurement and chemical process design; High level of written and verbal communication skills; Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through completion on time and on budget; Understanding and ability to execute DOEs, process validations and process characterizations; Working Knowledge of Six Sigma methodologies. Six Sigma Green / Black belt certification preferred.; Project management experience preferred; Understanding of GMPs and medical device regulations as they apply to manufacturing; Ability to travel up to 25%