Process Development Engineer (Eden Prairie)

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 pFMEAs
• Development and execution of Gage R&Rs

Education, Qualifications and Experience :

Working Conditions and Health & Safety :

Harland Medical Systems 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 Systems 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.