Senior R/D Engineer

Overview

Senior R&D Engineer supporting product development and sustaining engineering for medical devices within the NS Mechanical Engineering team.

What you'll do

• Lead and execute mechanical design activities for medical device products and components.
• Conduct engineering analyses and engineering reviews to meet safety, quality, regulatory, and manufacturing requirements.
• Develop and release component and assembly drawings using ASME standards and PLM systems.
• Support engineering change management and product release activities for sustaining engineering.
• Contribute to risk management, including DFMEA and related design history documentation.
• Apply regulatory and quality requirements (FDA, ISO, and design control) throughout development and sustaining projects.

What you'll need

• Bachelor’s degree in Mechanical Engineering.
• 8 to 12 years of product development experience in a regulated engineering environment.
• CAD experience with PTC Creo (Pro/ENGINEER) or SolidWorks, including detailed drawing creation.
• Expertise in GD&T and tolerance stack-up analysis.
• Experience with medical device design controls, technical documentation, and engineering change management.
• Experience delivering projects independently with cross-functional and global teams.

Nice to have

• FEA tools experience such as ANSYS Workbench.
• PLM knowledge including tools such as Agile or PTC Windchill.
• Knowledge of medical device regulations and standards including ISO 13485, ISO 14971, and 21 CFR Part 820.
• Experience supporting Design History File (DHF) deliverables and related risk documentation.
• Knowledge of advanced manufacturing methods such as additive manufacturing and 3D printing.

Details

• Location: Nanakramguda, Hyderabad, India.