Research & Development Engineer

The purpose of this position is to research, design and develop innovative solutions for medical devices manufactured in Tempe, Arizona. As a member of the Engineering team, responsibilities will include:

• Design and development of innovative concepts for changes to new and existing medical devices.
• Prototype and evaluate early-stage design changes using various rapid prototyping techniques (3D printing, machining, etc.) to prove design concepts.
• Support design verification activities for design changes, develop and execute design verification protocols to ensure product meets defined technical requirements.
• Contribute to design FMEA documentation to identify and mitigate design failure modes.
• Collaborate with marketing and sales groups to translate user needs and voice of customer to product design.
• Research and specify materials based on biocompatibility, mechanical properties, etc.
• Support engineering project tasks related to cost improvement projects and new product transfers.
• Implement and evaluate changes to existing processes designed to improve product quality, productivity, and overall equipment efficiency.
• Create and/or revise existing CAD models and drawings using SOLIDWORKS.
• Design and execute engineering studies, and analyze data using Excel and MINITAB.
• Apply statistical methods to estimate future manufacturing requirements and potential.
• Coordinate with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Apply statistical process control (SPC) methods for analyzing data to evaluate design requirements.
• Maintain a working knowledge of government and industry quality assurance codes and standards.
• Responsible for preparing and managing specifications for new and existing products.
• Maintain knowledge of good manufacturing practices and documentation, preferably in the medical industry, experiment design statistical procedures, and knowledge of computer programs.
• Develop, evaluate, and improve manufacturing methods; modify processes to improve safety and product quality, and/or reduce costs.
• Responsible for writing and executing test protocols and reports.
• All other duties as assigned by the Engineering Manager.

This position has no direct supervisory responsibility.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and stoop; use hands to finger, handleor feel; and reach with hands and arms.

The employee is occasionally required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. Occasional evening and weekend work may be required, as job duties demand.

This position requires 10%-15% travel.

• Bachelor's degree from four-year College or University in engineering or science preferred with 1-2 years of related experience and/or training. No degree and at least 5 years’ experience of specific experience with medical device manufacturing
• SOLIDWORKS and MINITAB experience preferred
• Experience or education related to design verification and validation
• Experience or education related to technical writing in an engineering context

• Excellent verbal and written communications required; strong facilitation and interpersonal skills required
• Experience with statistical software program preferred (MINITAB, etc.)
• To perform this job successfully, an individual should have knowledge of spreadsheet software and word processing software. Review drawings, key characteristics, tolerances, notes, specifications, etc.
• Provide Solid Works CAD support
• Experience in design for manufacturing preferred
• Problem…