About the role

The Role
As the Production Manager, you will be responsible for the daily execution of safe,
compliant, and cost-effective manufacturing operations for our medical devices
manufacturing lines. You will lead multi-shift teams across high-speed assembly, plastic
injection molding, and automated packaging, ensuring every product meets rigorous
global quality standards.
Key Responsibilities
 Drive Production Excellence: Oversee high-volume manufacturing processes,
including multi-cavity injection molding, extrusion and assembly lines
 Maintain Regulatory & Cleanroom Integrity: Ensure 100% compliance with
ISO Class 7/8 cleanroom standards and ISO 13485 regulations. Maintain
flawless Device History Records (DHR).
 Sterilization Coordination: Manage the seamless transfer of products to
downstream sterilization processes (ETO) in compliance with ISO 11135/11137.
 Continuous Improvement: Utilize Lean Six Sigma tools to optimize cycle times,
minimize plastic resin and component scrap, and drive right-first-time quality
metrics.
 Validation & Engineering Support: Partner with manufacturing engineers to
execute Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for
new and modified automated equipment.

 Team Leadership & Safety: Lead, mentor, and develop shift supervisors,
technicians, and operators. Cultivate a proactive culture of safety, accountability,
and continuous training.
What We Are Looking For
 Education: Bachelor’s degree in mechanical, Plastics, Chemical, or Industrial
Engineering, or a related technical discipline.
 Experience: 5+ years of progressive leadership experience in a medical device
manufacturing environment, specifically managing syringes or high-volume
disposable devices.
 Technical Expertise: Robust knowledge of injection molding , automated
assembly lines, sterilization and cleanroom bioburden control protocols.
 Skills: Strong analytical problem-solving abilities, excellent communication skills,
and a proven track record of managing multi-shift manufacturing teams.
What We Offer
 Competitive salary and performance-based bonus structure.
 Opportunities for professional development and career advancement.