Senior Engineer, Advanced Manufacturing Engineering Group

BD in Covington, GA

  • Type: Full Time
position filled
Job Description Summary
Summary/Purpose of Position

The Advanced Manufacturing Engineer (AME) 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 will support sustaining engineering activities including capacity expansions and failure analysis on existing platform based products.Job Description
Essential Duties and Position Responsibilities

Support new product team design activities including:

Provide concept development and Product Performance Specification (PPS) 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)

Qualifications, Knowledge and Skills Required

BS degree in Engineering required (mechanical, chemical, biomedical or equivalent).
BS degree with minimum 5 years relevant experience desirable
Demonstrated proficiency in equipment and tooling procurement and process design and development (assembly and associated process development)
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 and scheduling experience preferred
Understanding of GMPs and medical device regulations as they apply to manufacturing
Ability to travel up to 25%

Primary Work Location
USA GA - Covington BMDAdditional Locations
Work Shift
NA (United States of America)

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