Research & Development Engineer I

Erbe USAorporated•Tempe, AZ

5d•Onsite

About The Position

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, management of 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.

Requirements

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
Excellent verbal and written communications required; strong facilitation and interpersonal skills required
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.
Employees must be legally authorized to work in the United States.
Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

Nice To Haves

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
Experience with statistical software program preferred (MINITAB, etc.)
Provide SolidWorks CAD support
Experience in design for manufacturing preferred

Responsibilities

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, management of 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.