Engineer, Process

Responsibilities and Essential Functions

• Lead project teams to increase productivity, reduce scrap, implement lean manufacturing, improve system availability, safety, and product quality.
• Perform root cause investigations for the NCR or CAPA processes. Report findings to cross-functional team, propose and implement corrective actions, and verify corrective action effectiveness.
• Develop SOPs for equipment operation, part inspection, equipment change over, and preventive maintenance activities that are current and accurate.
• Write Capital Appropriations for new equipment required to support Manufacturing. Create justification for approval of investments. Work with vendors to provide quotes and identify system specifications. Coordinate project timelines to meet manufacturing requirements.
• Write, review, and execute PVP, IQ, OQ, PQ, FMEA, and RA documents and summaries. Familiarity with cGMPs, ISO, and other Medical Device Industry regulations and specifications.
• Support manufacturing by diagnosing system or process failures and working with Maintenance and/or the Tool Room personnel to implement system fixes.
• Collaborate with manufacturing to study, evaluate, and improve equipment and processes utilizing data-driven analysis, DOE, and any other applicable methods.

Authorities

• Reject change orders thru the design change system.
• Reject validation protocols, executed protocols that have not followed internal procedures or cGMP practices.

Qualifications

• Bachelor’s degree in engineering or related field.
• 3-5 years of relevant work experience.
• Experience working in the medical device field preferred.
• Must be able to read, write, and understand English.
• Education, training, and/or experience with plastics desirable.
• Experience with equipment and processes used to assemble, test, and package plastic components.