Product Development Engineer II
Website Olympus Corporation of the Americas
In order to be considered, applicants must apply at our website: https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=2795&company=olympuscorP
The Product Development Engineer II is responsible for supporting and assisting all aspects of product development. Primary responsibilities of the position are assisting other engineers in defining product specifications, design inputs, product design, verification testing and supporting design validation studies. Other activities include evaluating alternatives including cost and risk, supportability and analyses for total device. He or she must understand medical device design control requirements and be able to work effectively in a cross functional team. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development. May serve as a core or extended team member on PRP/NPD projects.
* Assists other engineer working with Marketing to facilitate proper design of new or modified products.
* Works with vendors involved in product development and ongoing production.
* Conducts testing and collects the necessary product data.
* Assists other engineers working with Marketing to define and specify new product user requirements, design inputs for medical devices.
* Designs various aspects of medical devices with a focus on design for manufacturability, ergonomics and COGS.
* Supports product verification and validation testing requirements, author testing protocols and testing reports to ensure products meet specification.
* Investigates and solves critical production product/process problems on demand.
* Performs design analysis, e.g. tolerance stack-ups, strength of materials (factor of safety), FEA risk analysis, etc. required for new and existing products.
* All Other Essential Duties as directed.
* Bachelor’s degree in Engineering or equivalent in years of industry experience.
* Minimum of 2 years of related experience, or 0 years with Master’s degree.
* Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
* Knowledge of statistical analysis package (Stat Ease, Minitab) preferred.
* Experience with the creation and critical review of engineering drawing and specification documentation.
* Understands geometric dimensioning and tolerance experience.
* Proficient in Microsoft Windows environment, Outlook, excel, MS project, 3D CAD/CAM software.
* Strong problem solving skills.
* Must be able to prioritize and organize work.
* Must be able to collaborate and work well within cross-functional teams.
* Must be able to communicate effectively at all levels, both verbally and in writing.
* Must be able to organize and align project tasks and issues.
* Ability to adapt to and support change with a positive attitude.
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