Senior Principal Mechanical Design Engineer

A Day in the Life

The Senior Principal Engineer – FEA & CFD provides thought leadership in advanced simulation to support product design, development, and verification of medical devices. This role acts as a recognized technical authority for structural and fluid simulations, driving modelling strategy, solving complex engineering problems, and influencing product and technology decisions across R&D teams. The role partners closely with cross functional stakeholders to enable simulation driven development and to support regulatory compliance.

Responsibilities may include the following and other duties may be assigned:

• Lead advanced FEA and CFD analyses for complex medical device systems, including nonlinear structural, dynamic/impact, and advanced material modelling.
• Plan, execute, and review CFD simulations for internal and external flows, multiphase flows, heat transfer, fluid–structure interaction (FSI), and particle tracking.
• Define, communicate, and drive simulation strategies aligned with product requirements, design objectives, risk management, and verification needs.
• Provide actionable design guidance based on structural, thermal, and fluid behaviour insights to improve performance, reliability, and manufacturability
• Model Development, Verification and Validation
• Develop, calibrate, and maintain robust FEA/CFD models, including material models, contact definitions, and boundary conditions.
• Establish and maintain simulation verification and validation (V&V) frameworks and procedures to ensure model credibility and appropriate use.
• Correlate simulation results with bench testing, animal studies, clinical data, and relevant historical data, and document evidence in DHF and regulatory submissions.
• Support design verification, risk mitigation, and root cause investigations using simulation to explain failure modes and inform corrective actions.
• Innovation and Continuous Improvement
• Drive innovation in simulation methodologies, including automation, reduced‑order models, surrogate models, and digital twin approaches.
• Evaluate and implement emerging simulation technologies, tools, and workflows to improve efficiency, accuracy, and scalability.
• Develop and promote best practices, standards, and templates for FEA/CFD within the organization.
• Collaboration and Influence
• Partner with systems engineering, design engineering, test, quality, manufacturing, and regulatory teams to integrate simulation into end‑to‑end product development.
• Communicate complex simulation results and trade‑offs clearly to technical and non‑technical stakeholders, influencing design and program decisions.
• Represent simulation in design reviews, technical forums, and regulatory interactions as required.
• Coaching and Capability Building
• Mentor and coach engineers in FEA/CFD methods, tools, and best practices, building a strong simulation community of practice.
• Lead technical reviews of simulation work products, providing guidance and feedback to elevate quality and consistency.
• Contribute to talent development by identifying skill gaps and supporting training plans in advanced simulation.

Required Knowledge and Experience:

• Bachelor's or Master's degree/ Phd in Mechanical Engineering or a related discipline from a recognized institution (IITs, NITs, IISc or other premier institutes preferred).
• Must have 20+ years of experience in simulation‑driven product development, preferably in highly regulated industries.
• Deep, hands‑on expertise in FEA tools such as LS Dyna, ANSYS, Abaqus and CFD tools such as Fluent, Star‑CCM+ (or equivalent).
• Proven track record of leading complex, high‑fidelity structural and CFD analyses and translating insights into design decisions.
• Demonstrated ability to independently drive multiple projects, manage priorities, and deliver high‑quality work in ambiguous, fast‑paced environments.
• Strong communication and presentation skills, with experience influencing stakeholders and driving alignment across cross‑functional teams.
• Knowledge of simulation credibility frameworks and model risk assessment (for example ASME V&V 40), with experience contributing to regulatory submissions and technical reviews.
• Familiarity with ISO 13485, design controls, risk management, and product verification processes in a regulated environment.
• Strong understanding of materials such as metals, polymers, hyperelastic materials, and composites, and their application in simulation models.
• Nice‑to‑Have
• Experience across multiple medical device domains (implants, disposables, capital equipment, or other relevant product categories).
• Experience in design exploration and design optimization, including robust design techniques and multi‑objective optimization.
• Exposure to or experience with digital twin technologies and integration of simulations with test/field data.
• Experience defining or implementing automated simulation workflows, scripting, and data management for large‑scale analyses.
• Leadership Expectations:
• Recognized subject matter expert (SME) in simulation within the organization
• Provides technical leadership across programs and influences portfolio-level decisions
• Drives capability development, standardization, and adoption of simulation best practices
• Mentors and coaches engineers, fostering a high-performance, growth-oriented team culture