Job Description

Objective:

Responsible for engineering related support of manufacturing equipment and processes including continuous improvement, scrap reduction, and capacity improvements or optimization.

Responsibilities and Essential Functions:

• Lead project teams to increase productivity, reduce scrap, implement lean manufacturing, improve system availability, safety, and product quality. The ability to recognize opportunities and appropriately prioritize projects based on potential improvement and risk is imperative.
• 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.
• Coordinate engineering expertise to identify and implement safety improvements consistent with OSHA standards.
• 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 has not followed internal procedures or cGMP practices.

Work Environment:

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.

Qualifications:

• Bachelors’ 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.

Ambu Provided Training within the first six months:

• Agile
• Movex
• Scrum Process