Senior Manufacturing Engineer

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

If you’re a SeniorManufacturing Engineer who gets satisfaction from improving how things are made, solving difficult production problems and using data to make better engineering decisions, this role should appeal.As a Senior Manufacturing Engineer, you’ll work within an established medical device manufacturing environment where the focus is firmly on improving processes, increasing capacity, reducing variation and creating robust, scalable manufacturing solutions.This isn’t a role where you’ll simply maintain existing processes. You’ll be expected to challenge them.

The Role

You’ll take ownership of manufacturing and process engineering activities, working closely with Production, Quality and R&D to improve manufacturing performance while maintaining compliance with ISO 13485 and wider medical device requirements.

• Analyse manufacturing KPIs and production data to identify opportunities for continuous improvement, increased throughput, improved yield and reduced waste.
• Lead manufacturing process development, optimisation, line balancing and capacity improvement activities.
• Conduct structured root cause analysis using tools such as 8D, DMAIC, Fishbone and 5 Whys.
• Apply lean manufacturing, Six Sigma and statistical techniques to reduce variation and improve process capability.
• Lead continuous improvement projects from problem identification through implementation and effectiveness review.
• Design and execute engineering trials, experiments and validation protocols, analysing results to support evidence-based decisions.
• Support CAPA, non-conformances, audit findings and manufacturing investigations.
• Develop work instructions, process documentation and training materials within an ISO 13485 compliant QMS.
• Coach engineers and technicians in problem solving, process control and engineering best practice.

The successful SeniorManufacturing Engineer will be comfortable spending time close to production, understanding what the data is showing and translating that information into practical improvements.

Education and Experience

• A degree in Mechanical, Manufacturing, Biomedical Engineering or a related discipline.
• 5+ years’ engineering experience within medical devices or a comparable highly regulated manufacturing environment.
• Strong practical knowledge of ISO 13485 and regulated manufacturing.
• Demonstrable experience of continuous improvement, root cause analysis and lean manufacturing.
• Experience with process validation, equipment qualification and new equipment introduction.
• Strong statistical and data-analysis capability.
• Experience improving manufacturing yield, capacity, efficiency or process capability.
• Lean Six Sigma Green Belt or equivalent experience would be advantageous.

This would particularly suit a SeniorManufacturing Engineer who enjoys questioning existing processes, identifying where performance can be improved and building solutions based on evidence rather than assumption.You’ll need to be pragmatic, technically credible and comfortable influencing people across Manufacturing, Quality and Engineering.If you’re a SeniorManufacturing Engineer with a genuine passion for process improvement and want a role where your decisions can have a visible impact on manufacturing performance, this is an opportunity to take real ownership of improvement within a regulated medical device environment.