Process Engineer

Performance Health is seeking a Process Engineer to join our team in Akron, OH. In this role, you will be responsible for providing leadership and support for Quality and New Product Development projects. Leads initiatives to identify and improve the quality, production efficiencies, and safety of manufacturing operations.

Essential Job Duties & Responsibilities

Manufacturing Support:

• Experience with plastic and/or rubber sheeting and tubing extrusion
• Create and maintain production processing conditions and keep them up to date within document control system
• Create and maintain production operating instructions and provide training on new or updated procedures
• Implement continuous improvement/lean manufacturing initiatives to drive improvement using tools such as: Six Sigma, 5-S, and Kaizen
• Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product
• Operate various pieces of pilot and manufacturing equipment in the development and evaluation of raw materials and finished goods
• Lead projects to continuously improve existing processes or create new processes to support operations, increase uptime, and reduce scrap
• Provide technical support as needed to production. This could include providing this service on any of 3 shifts or on weekends
• Interfaces with others in the organization to ensure customer deadlines, quality requirements, and production metrics are met
• Interface with facility cost accountants to assist them in developing costing assumptions as it pertains to materials, machine run rates, and labor content
• Interface with customers to understand their product requirements. Ensure that formulations and processes are in place to meet these requirements
• Interface with purchasing to identify and evaluate new and replacement raw material ingredients

New Product Development:

• Work with Product Development, Operations, and Account Managers to establish well-defined design inputs and coordinate sample runs on production equipment
• Provide technical leadership on corporate level projects and develop manufacturing plans and timelines for scale up of and release of new products
• Work directly with quality team to identify and implement control plans for new products

Regulatory Support:

• Develop and execute Process Validation protocols and reports, fully documenting all IQ, OQ, and PQ activities for both existing and new processes. Actively participate on the validation team
• Lead PFMEA teams and own risk analysis activities throughout the plant
• Perform root cause analysis and lead teams assigned with addressing corrective actions
• Provide technical support during all external audits by FDA, ISO, and customers
• Participate as a member of the internal audit team by leading internal audits as well as participating/leading supplier audits
• Performs other duties as assigned

Job Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Industrial, Chemical, Biomedical)
• 4-6 years of process engineering experience in a manufacturing environment
• Ability to use the following applications: Word processing, spreadsheets, Microsoft Dynamics AX, and Document Control

Benefits

• Our benefits include healthcare; insurance benefits; retirement programs; paid time off plans; family and parenting leaves; wellness programs; discount purchase programs.
• This is a full-time position with a base salary range of $85,000 - $90,000 and the opportunity to earn bonus, plus benefits.

To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender, gender identity, sexual orientation, race, color, religion, national origin, disability status, protected Veteran status, age, genetic information, and any other characteristic protected by law.