MFG Process Engineer

Job Details

Description

Essential Responsibilities

Responsibilities

The purpose of this position is to design, develop, document, qualify, and improve production of medical devices manufactured in Tempe, Arizona. As a member of the Process Engineering team, responsibilities will include:

• Develop, test, and qualify new manufacturing processes and changes to existing manufacturing processes.
• 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.
• Develop, evaluate, and improve manufacturing methods, including process validations.
• 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. Perform verification and validation (IQ, OQ, PQ, FMEA), of product processes and designs.
• Analyze and plan work force utilization, space requirements, and workflow, and design layout of equipment and workspace for maximum efficiency.
• Assess current manufacturing processes, complete or update documentation, and identify improvement opportunities for cost savings, time savings, or scrap reduction.
• 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 the current process and process changes.
• 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.
• Create detailed work instructions to define manufacturing and assembly processes. 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.
  
  

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
• JDE/ERP experience preferred
• SOLIDWORKS and MINITAB experience preferred
• Experience or education related to manufacturing process 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
• Lean Six Sigma training preferred
• 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.