Job Title:
Process Engineer
Department:
Methods Development
Reporting To:
Methods Development Leader/Site Leader
Position Purpose:
The Process Engineer may perform activities concerned with the development of products, processes, and materials, by applying engineering disciplines. Will work as part of a multi- disciplinary team that may develop, modify, and implement procedures and work instructions for the design and manufacture of products and processes. May develop and implement measures, reports and monitor results and activities to determine areas for improvement
Responsibilities:
* Creates internal/customer testing plans and protocols required in the development of coating methods using a variety of chemistries (including lubricious and antimicrobial coatings) for coating various polymers and metals.
* Creates, revises, and maintains documentation required for Technology Transfer Books.
* Develops coating fixtures and setups for feasibility and production projects
* Process production orders where required
* Reviews product performance data derived from prototype and validation orders to see if more research and information needs to be collected and assesses the adequacy of the existing processes and equipment to drive continuous improvement.
* Prepares process flow diagrams and charts as required.
* In conjunction with the Quality department, specify or review In-Process or Incoming quality inspections, sampling plans and controls.
* Monitor, trend, analyze and report data from design, production, inspections, servicing, and suppliers to aid in the continuous improvement of designs, products, and processes.
* Perform specific projects as assigned.
* Work cross-functionally to resolve customer complaints regarding product performance.
* Participate in Material Review Board (MRB) meetings as required.
* Some national/international travel will be required with role (up to 10%).
Education, Qualifications & Experience:
* Bachelor's degree in engineering preferred.
* Detail oriented, highly organized individual.
* Integrity, high ethical standards.
* Excellent verbal, interpersonal and written communication skills.
* Self-starter, and motivated individual who works independently.
* Knowledge of ISO 13485 and QSR (FDA) environment expectations preferred.
* Ability to design and modify business systems, policies, procedures, work instructions, and specifications to correct and prevent business process issues.
* Ability to determine potential nonconformities and prevent, as well as correct detected nonconformities in process, product, and the Quality System.
* Analytical / problem solving skills with a demonstrated ability to collect, summarize and report technical information.
* Computer competency in MS Office - Word, Excel, Minitab Software and Outlook.
* Proficient in the application of statistical techniques, data analysis, and SPC.
Working Conditions and Health & Safety:
* Heated and air-conditioned office environment.
* ISO Class 7 cleanroom
* Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space
Harland Medical System's commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System's internal procedures, where deemed appropriate per assigned job functions.