Job Description:

Essential Responsibilities

This position will support the Development and Operations departments with the on-going projects, developing, and implementing process improvements to the assembly and production, and other duties, as assigned. The purpose of this position is to learn about designing, development, documentation, and qualification of disposable medical devices manufactured in Tempe, Arizona.

• Assess current manufacturing processes, complete or update documentation, and identify improvement opportunities for cost savings, time savings, or scrap reduction.


• Develops, evaluates, and improves manufacturing methods, including process validations


• Contributes ideas to management and production engineering team on process improvements


• Contributes to applying statistical methods to estimate future manufacturing requirements and potential. Performs verification and validation (IQ, OQ, PQ, FMEA), of product processes and designs.


• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.


• Maintains a working knowledge of government and industry quality assurance codes and standards.


• Responsible for understanding specifications.


• Performs activities of process/product validation.


• Maintains knowledge of good manufacturing practices and documentation, preferably in the medical industry, experiment design, management of statistical procedures, and knowledge of computer programs.


• Contributes to creating detailed work instructions, as necessary, to define manufacturing and assembly processes.


• Develops, evaluates, and improves manufacturing methods; assists in modifying processes to improve safety and product quality, and/or reduce costs.


• Contributes to designing and developing forms and instructions for recording, evaluating, and reporting quality and reliability data.


• Responsible for executing test protocols and processing data.

Supervisory Responsibility

This position is an individual contributor and 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, phones, photocopiers, filing cabinets and fax machines. 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 frequently is 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 part-time position. Days and hours of work are typically Monday through Friday, 8:00 a.m. to 5 p.m. but accommodations will be made for student flexibility. Occasional evening and weekend work may be required as job duties demand.

Travel

This position requires no measurable travel.

Required Education and Experience

• Current/Active STEM field student passionate about medical device manufacturing industry


• Ability to read and follow device inspection procedures


• Computer experience and skills including MS Word & Excel.


• Ability to use microscope


• Ability to read, write, and follow detailed procedures


• Demonstrated experience reading and preparing technical documentation


• Experience with statistical software program preferred (Mini-Tab, Applied Statistics, etc.) preferred.


• Experience with SolidWorks modeling, drawing, and assembly creation preferred.

Position Requirements

• Excellent verbal and written communications required; strong facilitation and interpersonal skills required.


• Must be able to communicate complex information to all levels within the organization.


• Demonstrated high quality computer skills including MS Office.


• Must be detail-oriented and produce high quality work in a high-volume environment.


• Must be able to handle confidential information in an appropriate and professional manner.


• Ability to remain flexible and open to change within a fluid global industry.

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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