Description
Our client are a global leader in bio-materials for the medical industry. They are hiring for a Senior Engineer to join their manufacturing facility in Pennsylvania. The role will support short and long term objectives for their medical products uses on/in the human body in a range of applications.
The Role
• 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 characterisation documents.
• Conduct design of experiments (DOE) in pursuit of process optimisation 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.
The Requirements
• Bachelor of Science degree in Chemical Engineering or Biomedical Engineering.
• Hands-on experience in a fast-paced manufacturing environment, preferably in medical equipment or devices.
• 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.
