Process Optimization: Analyze and improve manufacturing processes to increase efficiency and decrease downtime.
Production Monitoring: Oversee daily operations to ensure production schedules, quality standards, and safety regulations are met.
Troubleshooting & Maintenance: Troubleshoot equipment/jigs fixture issues and coordinate preventive maintenance or repairs.
Documentation & Standards: Develop, document, and maintain standard operating procedures (SOPs), work instructions, and safety protocols.
Collaboration: Work with engineering, facility, quality and production teams to resolve quality issues and implement improvements.
System: Able to use/read/edit CAD drawings, SAP BOMs, Engineering Change Control, etc
Staff Training: Train and certify production technician on new instrument assembly, processes, final tests and safety protocols.
Basic Qualifications:
A Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Manufacturing, or related fields) or a science-based degree with equivalent practical experience
Minimum of 3-5 years of experience in manufacturing engineering, product development, or related roles in the life sciences or medical device industry.
Strong understanding of engineering principles, product lifecycle management, and regulatory requirements (ISO, FDA, etc.).
Experience with CAD software (e.g., SolidWorks, AutoCAD), SAP and any simulation tools.
Excellent problem-solving skills with the ability to think critically and analytically in a fast-paced environment.
Experience project management skills, including the ability to learn multiple projects simultaneously.
Effective communication and presentation skills, with the ability to collaborate with cross-functional teams and senior leadership.
Ability to mentor, develop junior engineers and production technician
Preferred Characteristics:
Experience in life sciences, diagnostics, or analytical instrumentation industries.
Familiarity with regulatory requirements for medical devices (e.g., ISO 13485, FDA 21 CFR Part 820).
Knowledge of emerging technologies such as AI/ML, IoT, and digital health solutions.
Experience with statistical analysis and design of experiments (DOE) methodologies
