R&D Design Staff Engineer / Manager

Job Overview

Work Location: Peenya / Bengaluru (100% On-site)

The R&D Engineering Manager is responsible for leading end‑to‑end design solutions for medical device products, ensuring customer requirements are accurately translated into compliant, robust, and manufacturable designs. This role applies Design for Six Sigma (DFSS) and Design for Excellence (DFX) principles to optimize product performance, material selection, process design, and human factor considerations while maintaining full design traceability. The Staff Engineer drives technical problem solving, adheres to medical device design control and regulatory requirements, and leads design verification activities through prototyping, testing, metrology, and fixture development, working closely with cross‑functional teams to deliver high‑quality, reliable, and safe products.

Job Overview

• Lead and develop robust design solutions that meet customer requirements, ensuring full traceability across product systems, subsystems, interfaces, and components throughout the development lifecycle.
• Translate customer and regulatory requirements into detailed engineering specifications, validating alignment through rigorous design controls.
• Drive optimized product designs by considering material selection, product features, process design, manufacturability, and human factor requirements.
• Apply Design for Six Sigma (DFSS) methodology during design selection, optimization, and development to improve design robustness, reduce variability, and minimize design iterations and cycle time.
• Utilize empirical, statistical, and analytical tools to support sound engineering decisions, design trade‑offs, and risk‑based evaluations.
• Ensure design solutions incorporate all applicable Design for Excellence (DFX) principles, including manufacturability, serviceability, reliability, safety, and cost effectiveness.
• Identify, analyze, and resolve complex technical problems using structured problem‑solving methodologies and sound engineering judgment.
• Adhere to medical device design control requirements, ensuring compliance with local, national, international, and internal regulatory, safety, and quality standards.
• Plan and execute design verification activities, including prototyping, jig and fixture development, testing, and metrology, to confirm design intent and performance.
• Collaborate closely with cross‑functional teams (Quality, Manufacturing, Industrialization, Regulatory, and Supply Chain) to support successful product development and transfer.

Job Qualifications

• Bachelor’s or master’s degree in mechanical engineering.
• Demonstrated experience as a technical lead on cross-functional engineering projects.
• Design for Six Sigma (DFSS)
• Strong understanding of design controls, verification/validation, and risk management.
• Experience with people management, mentoring, and team development.
• Excellent communication, collaboration, and project management skills.
• Demonstrated first principles engineering and design skills (CAD/CAE).
• Ability to analyse, organize and present large amounts of data in a clear and concise manner.
• Disciplined, detailed and well organized with managing documentation in a regulated environment.
• Ability to execute concurrently multiple projects and manage priorities.
• Ability to work independently as well as delegate appropriately.
• Proficiency in Solid works CAD software (3D modelling, 2D drafting, surfacing)
• Experience in Plastic design, part detailing and Knowledge in Mold design.
• Experience working on both high-volume consumables and capital equipment product lines.
• Minimum 10+ years of experience in product development, preferably in medical devices.
• Knowledge of design for manufacturability, cost optimization, and reliability engineering.
• Exposure to regulatory requirements (FDA, ISO 13485) and quality systems.