Essential Responsibilities

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.

Supervisory Responsibility

This position has no direct supervisory responsibility.

Work Environment

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers and phones. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.

Physical Demands

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, handle or 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.

Position Type and Expected Hours of Work

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.

Travel

This position requires 10%-15% travel.

Required Education and Experience

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

Position Requirements

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 SolidWorks CAD support
Experience in design for manufacturing preferred

Competencies

Problem Solving/Analysis
Results Driven
Detail Orientation
Customer Focus
Technical Capacity
Communication Proficiency

Additional Eligibility Qualifications

None required for this position.

Work Authorization/Security Clearance

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.

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

Other Duties

Please note this position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.

Erbe Medical, LLC

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