Senior Manufacturing Engineer I - Exton, PA

Senior Manufacturing Engineer I - Exton, PA

Senior Manufacturing Engineer I

Exton, PA

On-site

As a Senior Manufacturing Engineer I, you will support the short-term and long-term objectives of the Operations team as they produce medical products used on or in the human body at our Exton, PA facility. Within our ISO 8 clean rooms, you will support one or more manufacturing areas related to Ceramics, Collagen, Polymer, Mechanical Device, Polyurethanes, or Silicon Hydrogel technologies. As the process owner, you will lead or support daily goal attainment, safety upgrades, yield improvements, process and equipment upgrades, and cost savings projects.

Key Responsibilities

• Develop and monitor process-centered metrics and then use those metrics to drive process improvements.
• Lead resolution of process and equipment issues as needed to keep product moving towards shipment.
• Lead, support, and role model SHE activities and processes and impact the safety and environmental performance of the business through proactive projects.
• Write, approve, and execute IQ, OQ, POQ, PQ, and process characterization documents.
• Conduct design of experiments (DOE) in pursuit of process optimization and capture findings in technical documents.
• Identify significant opportunities for improvement (e.g yield, equipment, cost savings), justify the necessary resources, and then implement your solution on-time and within budget.
• Lead short-term (NCR) and long-term (complaints and CAPA) efforts to improve quality.
• Lead cross-functional teams and provide technical expertise on a variety of business-related challenges.
• Mentor junior engineers and/or co-ops within their area of responsibility.

You Bring:

• Bachelor of Science degree in Mechanical, Chemical, or Industrial Engineering. Other engineering-related degrees will be considered with relevant experience.
• 7+ years of hands-on experience in a fast-paced manufacturing environment, preferably in medical equipment or devices.
• Demonstrated experience designing, building, and maintaining small tools and fixtures using Creo or related software packages.
• Experience generating ideas, getting business support, and then driving the idea to an implemented solution.
• Experience in a regulated environment, preferably the medical device industry. ISO 13485 and 21CFR820 are highly desirable.
• Ability to manage multiple projects while maintaining day-to-day responsibilities.
• Demonstrated use and interpretation of MiniTab software package, specifically process capability, DOE, and control charts.