Job Description

Job Title: Process Development Engineer

Department: Methods Development

Status: Full Time - Exempt

Reporting To: Business Unit Manager/Business Unit Director

Position Purpose:

The Process Development Engineer is capable of working within a dynamic group, to meet project goals and timelines. This position must be well organized, detail oriented, and have the flexibility to handle multiple project assignments.

This position requires a quick learner, who is hands on, and can solve technical problems by thinking outside of the box. Working both independently and on a project team will be critical. The selected individual must be able to promote a positive work ethic and demonstrate commitment to Harland Medical Systems corporate values.

Responsibilities:

The Process Development Engineer is responsible for:

• Preparation of R&D lot travelers
• Understanding of materials and fixturing
• Developing processes for the coating of medical devices within a FDA compliant design control system all in a fast-paced environment.
• Capable of creating internal test plans and protocols, which are required in the development of coating methods.
• Provide technical support including writing product testing protocols, process documents and work instructions to ensure ISO requirements are met. Communicating results to project leaders and team members will be key.
• Creation and ongoing support of pFMEA’s
• Development and execution of Gage R&R’s

Education, Qualifications and Experience:

• Bachelor of Science Degree in Engineering and/or a Technical Degree with minimum of 5 years related experience
• Strong analytical/problem-solving skills with demonstrated ability to collect, summarize and report technical information
• Proficient in application of various statistical techniques and analysis (Minitab a plus)
• Knowledge and experience working with ISO 13485, 10993, and 21CFR Part 820 regulations
• Knowledge of manufacturing methods
• Ability to design simple fixturing with the use of Solidworks
• Self-starter and motivated individual who works both independently and with a team
• Detail-oriented and highly organized individual
• Excellent oral and written communication skills
• Proficient in the use of Office, Word, and Excel.
• Previous experience working in a cleanroom environment

Working Conditions and Health & Safety:

• Heated and air-conditioned office environment
• ISO Class 7 cleanroom
• Laboratory
• 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.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.

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