Demo

Senior Engineer

Mackinnon Bruce International
Pennsylvania Furnace, PA Full Time
POSTED ON 1/26/2025
AVAILABLE BEFORE 4/25/2025

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.

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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 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.

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.
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