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Development Engineer -

Job Code - EC0809

Job Role Product Development Engineer Medical Interonnect
Locations San Diego, CA, Florida or Rhode Island
Reports to Product Development & Engineering Manager – Medical products
Resume to:

Description This position requires design experience in a highly regulated environment such as medical, automotive or military along with experience in electromechanical assemblies. Typical applications will include patient monitoring, surgical and imaging as well as other electronic connectivity requirements in the medical field. The emphasis of this position will be on the development of new products both driven by internal specifications as well as external customer requirements including, design, development, testing and project management in a high-paced, results driven environment. Ideally this person would have experience in stamping, injection molding, FEA and DOE/test methodologies with knowledge of RoHS and ISO-13485 requirements.

• Develop products based on customer specification or internal marketing initiatives
• Assist Business Development & Sales by performing customer specification reviews and developing product requirements based on customer specs
• Turn Concepts into product designs, creating and maintaining the product throughout the product lifecycle
• Create 3D models and 2D drawings in an ISO-13485 design and development, production release and PDM environment
• Perform analysis such as FEA, CFD, Mold Flow and tolerance analysis where applicable
• For some projects, maintain project schedule, action list, facilitate team meetings as required, communicate with suppliers and other functional disciplines and communicate with customers adhering to ISO 13485 QMS procedures
• Develop prototyping and test plans to support concept, design, development and production validation phases
• Assist in the creation of DVP&R validation plans, oversee and sometimes perform capability or validation testing, review and sometimes write test procedures and reports and provide Engineering disposition/conclusions
• Troubleshooting of performance or manufacturing issues on new designs to determine root cause

• BSME degree with a minimum of 10 years’ experience in the Design and Development of custom products in a regulated environment (Medical Preferred)
• Strong understanding of 3D CAD systems (SolidWorks preferred)
• Strong problem solving and analysis capabilities including FEA, CFD, GD&T and tolerancing
• Experience with Microsoft Office suite: Word, Excel, PowerPoint, Project
• Technical working knowledge of connector systems and electrical interconnect design requirements
• Technical understanding of stamping, drawing and injection molding processes
• Experience working with ERP systems

Resume to: