Role OverviewThis position is responsible to support the Global Operations Advanced Manufacturing Engineering (AME) team in developing, qualifying, and launching new products for the Sports Medicine Franchise.
The Advanced Mfg. Engineer II will be the operations new product development representative and will work with cross-functional teams both locally and at various manufacturing sites.
This position is responsible for ensuring that timeline milestone commitments are achieved while meeting all Safety, Quality, and Cost requirements.
We are looking for a motivated, driven, and technically curious individual that can drive execution in a very diverse and challenging environment.
This individual will be working in both cross-functional group settings as well as independently with the support of a technically strong, experienced, and highly motivated team.
Under supervisory direction, assists in the development of capable processes and ensures efficient and effective transfer of product from design into production.
ResponsibilitiesSupports process development, equipment specification, equipment acquisition, and implementation.Works with partner groups at manufacturing sites to gain alignment and support to achieve project objectives.
Supports design for manufacturability (DFM) and process development efforts.Supports PFMEA, Process Mapping and Critical to Quality documentation.
Supports the creation and review of process flow charts, assembly line layouts and assembly capacity balance analysis.Provides input for the development of tooling and fixtures required to support NPD activities.
Supports the development and evaluation of new processes through lab studies, Design of Experiments (DOE) and testing methods.
Creates specifications, drawings, process instructions (MPIs), bills of materials (BOMs) and routers.Coordinates, participates and / or manages prototype builds, verification / validation builds.
Supports problem solving, root cause analysis and implementation of sound engineering solutions.Supports the development, execution, data analysis, and report writing for validation activities (IQ, OQ, PQ and TMV).
Consistently meets expectations while accomplishing tasks and meeting goals and objectives in a timely manner.RequirementsEducation Experience : Bachelor’s Degree in Science or Engineering and at least 2 years’ professional work experience in new product developmentExperience in the medical devices industry is preferred.
Must be able to communicate effectively, while working with cross-functional teams, in order to achieve desired results.Assembly fixture design and fabrication knowledge are preferred.
Must build productive internal / external relationships and collaborate with others in teamsMust be able to complete assignments with directional input and periodic guidance.
The ability to understand, interpret, follow, and improve Quality Systems.Requires organizational and time management skills.
Ability to understand basic technical issues and develop solutions with the scope of responsibilities.Basic knowledge of Operations deliverables / documentation is preferred.
Project management experience and statistical knowledge are a plus.Duties and responsibilities may change as business needs change.
Strong verbal and written communication and presentation skills.English level : C1 minimum.