Role Summary:
The Advanced Process Optimization Specialist drives technical excellence in manufacturing process development, improvement, and support within a regulated medical device environment.
This role focuses on process optimization, new product introductions, and ensuring compliance with quality and regulatory standards.
Key Responsibilities:
* Develop, validate, and optimize manufacturing processes (IQ/OQ/PQ).
* Lead process improvements to increase yield, quality, and efficiency.
* Support new product introduction (NPI) from concept to production.
* Maintain compliance with ISO and FDA requirements.
* Lead root cause analysis and CAPA activities.
* Drive Lean and Six Sigma initiatives to reduce cost and waste.
* Provide technical mentorship to engineers and technicians.
* Specify, qualify, and maintain production and automation equipment.
Qualifications & Experience:
* Bachelor's degree in Mechanical, Manufacturing, Biomedical, or Industrial Engineering (Master's preferred).
* 5+ years' experience in a regulated manufacturing environment, ideally medical devices.
* Strong knowledge of GMP, ISO, and FDA 21 CFR Part 820.
* Skilled in validation, process development, DOE, and statistical analysis.
* Experience with Lean / Six Sigma methodologies (certification an advantage).
* Excellent communication, teamwork, and project management skills.