Senior Manufacturing Engineer: Process Excellence in Med Devices

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Aurora Lifesciences is seeking a Senior Manufacturing Engineer to own manufacturing and process engineering activities in a regulated medical device setting. You will work with Production, Quality and R&D to improve performance while ensuring ISO 13485 compliance and safety.

Responsibilities include leading process development, line balancing, capacity improvements, and structured root cause analysis, applying Lean Six Sigma and statistical methods to reduce variation and improve capability.

Qualifications

• Degree in Mechanical, Manufacturing, Biomedical Engineering or related discipline.
• Strong continuous improvement experience in a regulated medical device or similar environment.
• Solid knowledge of ISO 13485 and regulatory manufacturing.
• Experience with process validation, equipment qualification and new equipment introduction.
• Lean Six Sigma Green Belt or equivalent advantageous.

Responsibilities

• Analyse manufacturing KPIs and production data to identify continuous improvement opportunities.
• Lead process development, optimization, line balancing and capacity improvements.
• Perform root cause analysis using structured tools (8D, DMAIC, Fishbone, 5 Whys).
• Apply lean manufacturing and Six Sigma to reduce variation and improve process capability.
• Design & execute trials, validation protocols, and data-driven decision making.
• Support CAPA, non-conformances, audits and investigations.
• Develop work instructions and ISO 13485-compliant documentation.
• Coach engineers and technicians in problem solving and process control.

Education

Mechanical, Manufacturing, Biomedical Engineering or related

Tools

8D

DMAIC

Fishbone

5 Whys

Job description

Aurora Lifesciences is seeking a Senior Manufacturing Engineer to own manufacturing and process engineering activities in a regulated medical device setting. You will work with Production, Quality and R&D to improve performance while ensuring ISO 13485 compliance and safety.

Responsibilities include leading process development, line balancing, capacity improvements, and structured root cause analysis, applying Lean Six Sigma and statistical methods to reduce variation and improve capability.