Senior R&D Engineer

We are searching for the best talent for Senior R&D Engineer. 

You will be responsible for:

• Analyze product and process requirements (materials, quality, EHS) and perform risk and root cause analysis.
• Develop and improve product designs, processes, equipment, test methods, and procedures; define technical requirements.
• Plan and execute validation and verification studies, including test plans, protocols, data analysis, and issue resolution.
• Implement new or modified products and processes, author SOPs, protocols, risk assessments.
• Maintain compliance with cGMP, ISO standards; update procedures, support audits, and resolve CAPAs/NCRs.
• Lead complex design analysis and verification testing.
• Provide technical leadership for new product development and process optimization.
• Troubleshoot and resolve technical issues in product and process development.

Qualifications / Requirements:

• Bachelor’s degree in Engineering or related field with minimum 6 years of experience in a regulated industry.
• Master’s degree preferred with minimum 4 years of experience.
• Demonstrated ability to lead small to mid-scale projects and mentor junior engineers.
• Strong knowledge of Design Control and compliance standards (cGMP, ISO).
• Hands-on experience with complex validation and verification studies.
• Proficient in risk analysis and troubleshooting technical issues.
• Proficiency in English.

Preferred specific knowledge and skills:

• Analysis of datasets using Python or MatLab.
• Designing 3D models using SolidWorks.
• Experience in rapid prototyping techniques using 3D printing.
• Proficient in the use of Microsoft Project.
• Six Sigma Certified Green Belt / Black Belt.
• Knowledge in high precision machining (lathing and milling).
• Knowledge in high precision injection molding.

Required Skills:

Problem Solving, Process Engineering, Technical Credibility

Preferred Skills:

Analytical Reasoning, Coaching, Computerized Equipment Skills, Emerging Technologies, Engineering, Gemba Kaizen, Mechanical Equipments, Process Control, Process Oriented, Product Improvements, Purchasing, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Teamwork, Technical Research, Technologically Savvy