Position Title
Product Development Engineer
SBU
OEM
Department
Engineering
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
3-5 years' experience in Medical Device manufacturing. Good working knowledge of GD&T. Proven track record for project management. Good working knowledge of manufacturing processes related to medical device manufacturing.
Qualification Requirements
BS Mechanical Engineering, or the equivalent in a related field.
Preferred Qualifications
Proficient in 3D Modeling, preferably SolidWorks. Proficient in MS Office Products. Excellent oral and written communication skills. Ability to prioritize and work independently.Ability to manage development programs across multiple locations and project teams. Familiar with the design controls, FDA regulation, and GMP practices, QSR requirements. Eperience with Risk Analyst. Relies heavily on experience and judgment to plan and accomplish goals.
Responsibilities
The Product Development Engineers is responsible for the design and development of new products, for sustaining existing products, including design calculations, creating solid models, and detailing prints with minimal supervision, and for interfacing with customers, vendors, and internal departments, all of which are essential to achieving our goal of on-time delivery and high quality products.
ESSENTIAL DUTIES AND RESPONSIBILITES:
Use of SolidWorks (3D Modeling) to create designs and drawings. Develop new products and improve existing products. Address customer's issues and improve performance, appearance, and impact of product on the end-user. Review and approve customer orders for manufacturing. Research new materials, assembly methods, and manufacturing processes. Develop B.O.M.s and assembly method. Develop design controls from initial customer request through Verification/Validation of products. Initiate, process, and review Engineering Change Notices. Provide support to manufacturing, marketing, and customer service; interface with customers and suppliers. Manage project as a team leader, whose duty encompasses the full scope of the project. Developing drafting/design standards to increase efficiency. Writing, monitoring, and reviewing test protocols. Determine product specifications/limitations. Implement cost reduction by working closely with manufacturing to reduce scrap and waste. Review routings and add additional information to prints as required. Perform analysis verification of design, which may include calculation and/or FEA.
