R&D Engineer II

Erbe USA Incorporated • Tempe, AZ

2d

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:

Independently lead design and development activities for product changes and
new product components from concept through transfer to manufacturing.
Plan and execute design verification and validation strategies, including
protocol development, test method definition, data analysis, and final
reporting. Contribute to design FMEA documentation to identify and mitigate
design failure modes.
Prototype and evaluate early-stage design changes using various rapid
prototyping techniques (3D printing, machining, etc.) to prove design
concepts.
Lead cross-functional project activities with Quality, Regulatory,
Manufacturing, Supply Chain, and Marketing to ensure project objectives are
met.
Drive root cause investigations and implement corrective design or process
solutions for product or manufacturing issues.
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.

Requirements

• Bachelor's degree from four-year College or University in engineering or science preferred with 3-5 years of related experience and/or training or Master’s degree in engineering or science with 2-3 years of related experience and/or training
• 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
• 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 SolidWorks CAD support

Nice To Haves

• Experience with statistical software program preferred (MINITAB, etc.)
• Experience in design for manufacturing preferred

Responsibilities

• Independently lead design and development activities for product changes and new product components from concept through transfer to manufacturing.
• Plan and execute design verification and validation strategies, including protocol development, test method definition, data analysis, and final reporting. Contribute to design FMEA documentation to identify and mitigate design failure modes.
• Prototype and evaluate early-stage design changes using various rapid prototyping techniques (3D printing, machining, etc.) to prove design concepts.
• Lead cross-functional project activities with Quality, Regulatory, Manufacturing, Supply Chain, and Marketing to ensure project objectives are met.
• Drive root cause investigations and implement corrective design or process solutions for product or manufacturing issues.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level