About this role
Work Flexibility: Hybrid
What you will do-
• Support New Product Development (NPD) Design Quality Engineering activities for orthopedic medical devices, with a primary focus on risk management, usability engineering and design control as per the project and business need. • Effectively collaborate with cross functional partners (Product Development, Regulatory Affairs, Quality, Clinical, Manufacturing, Packaging, Sterility, etc. and ensure compliance with applicable Quality System and regulatory requirements throughout the development process. • Lead risk management and usability activities in accordance with applicable standards and internal procedures including formative and summative evaluations. Drive identification, assessment, and mitigation of product and process risks. • Drive continuous improvement initiatives and identify opportunities to improve quality, efficiency, and consistency of deliverables.
What you will need-
Required skills-
• Bachelor's or master’s in mechanical engineering, bio-medical or similar domain. • Experience- 4 years -7 years • Experience of working in regulated environment such as FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1, and ISO 14971 and experience with Product Lifecycle Management (PLM) tools, requirement management tools (Jama etc) and project management tools (JIRA etc) • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing.
Preferred skills-
• Knowledge of EU Medical Device Regulation preferred • Familiarity with design reviews and Design History File (DHF) documentation creation and organization. • Experience with 3D CAD software, especially Creo from PTC and experience with surgical trays.
Travel Percentage: 10%