Sustaining Engineer

ESSENTIAL TASKS AND DUTIES INCLUDE:

• Serve as hands-on, technical contributor in developing new products to support existing product lines with minimal oversight
• Document designs by constructing solid models, assemblies, and drawings with SolidWorks
• Fabricate prototypes utilizing internal and external resources
• Perform structural, dimensional, fluid, vibration, thermal, and reliability analyses to support new and existing product designs
• Work with internal and external manufacturing partners to ensure design for manufacturability and serviceability
• Prepare and lead design reviews, and contribute to peer design reviews
• Develop specifications, test methods, and conduct engineering feasibility testing of new and existing product designs
• Identifying and qualifying new suppliers as necessary
• Write test protocols and reports in support of product and process verification/validation
• Prepare engineering change orders and documentation
• Work cross-functionally as needed to address field issues and defects to determine root-cause and implement corrective actions as necessary
• Perform tasks and duties as required

BACKGROUND AND QUALIFICATIONS:

• BSME with 8 years or MSME with 6 years mechanical design/engineering experience or equivalent combination of education and experience
• Experience with FDA, ISO, and IEC standards a plus
• Proven ability to develop mechanical designs using best engineering practices
• Must have experience with applicable manufacturing processes such as injection molding, thermoforming, machining, and plastics assembly
• Experience developing and troubleshooting electromechanical systems
• Must have expertise with SolidWorks CAD software
• Full life cycle medical device development experience preferred
• Experience with analytical software packages preferred
• Must be reliable and able to work both independently and in a team environment with outstanding written and verbal communication skills