Job Description

Job Summary

• Minimum experience of 4 years in Medical devices - Manufacturing Engineering.
• Good Experience working on Process Validations (IQ, OQ, PQ)
• Experience developing manufacturing processes and technologies, which includes process characterization
• Experience working on PFMEAs
• Experience performing Data analysis (Minitab)
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Key Responsibilities

1. Optimize manufacturing processes to improve quality, efficiency, and productivity.
2. Troubleshoot production and equipment issues to minimize downtime.
3. Lead process validation, FMEA, and continuous improvement activities.
4. Ensure compliance with quality, GMP, and regulatory requirements.
5. Collaborate with cross-functional teams on manufacturing and product development projects

Skill Requirements

1. Manufacturing process development and optimization
2. Lean Manufacturing and Continuous Improvement
3. Process Validation and FMEA (Failure Mode & Effects Analysis)
4. Root Cause Analysis and Problem Solving
5. Tooling, fixture, and equipment design
6. Design for Manufacturability (DFM)
7. Production troubleshooting and equipment support
8. Quality systems knowledge (FDA, ISO 13485, GMP)
9. CAD software proficiency (SolidWorks, AutoCAD, Creo)

Other Requirements

1. Optional But Valuable: Cmmi Certification.
2. Optional But Valuable: Relevant Certifications In Software Development Or Manufacturing Processes.