Senior Mechanical Engineer

Job Description: Senior Mechanical Design Engineer — Medical Device (Mechanical / Mechatronics)

About the Role

We are looking for an experienced Senior Mechanical Design Engineer to lead the mechanical architecture, design, and validation of a next-generation electromechanical robotic medical device. This role requires a highly motivated engineer who can transform product concepts into robust, manufacturable, and validated mechanical systems while collaborating closely with Electronics, Embedded Software, AI/ML, Robotics, Quality, and Manufacturing teams.

The ideal candidate should possess strong expertise in precision mechanical design, motion systems, product development, structural analysis, simulation, tolerance engineering, prototype development, design/product verification and validation against medical device safety standards. The individual will own the complete mechanical lifecycle from concept through production release while mentoring a team of design engineers.

Key Responsibilities

• Lead the complete mechanical product development lifecycle from concept generation to production release.
• Lead end-to-end mechanical design of a multi-subsystem electromechanical medical device, including motion subsystems, structural/support components, and moving mechanical assemblies.
• Develop innovative concepts for robotic and electromechanical systems considering manufacturability, reliability, cost, and serviceability.
• Own design-input to design-output traceability: translate clinical/user needs and applicable standards into detailed mechanical specifications, drawings, and tolerances.
• Perform and review motor/actuator sizing (torque, force, speed, duty cycle),Belt and pulley selection, gear ratio calculation, Spring calculation, Bearing selections, Pneumatic system sizing, power transmission calculations, Engineering analysis and structural calculations (static/dynamic load, safety factors, fatigue life) for moving subsystems.
• Lead prototype/product development by Preparing prototype BOMs, Supporting vendor development, Coordinating fabrication, Assembly planning, Prototype debugging, Design iteration, Engineering change implementation and Product Verification & Validation
• Drive DFM/DFA (design for manufacture and assembly), material selection, and tolerance-stack analysis across molded, sheet-metal, and machined components.
• Lead structural and dimensional verification against safety-critical requirements typical of medical devices (mechanical hazard/pinch-point analysis, stability, structural load ratings, thermal safety limits, ingress protection).
• Own the mechanical content of the Design History File (DHF) under ISO 13485, including design input registers, verification/validation protocols and reports, risk-management inputs, and change control.
• Build, test, and iterate functional prototypes; plan and execute bench-level and system-level verification tests.
• Collaborate cross-functionally with electronics, embedded/software, and quality/regulatory affairs to ensure the mechanical design supports safe, reliable, and manufacturable system integration.
• Mentor and technically guide junior/mid-level design engineers; review their CAD, calculations, and test data.
• Manage external vendors/suppliers for custom components (actuators, motors, gearboxes, sensors, mobility components) and manage BOM cost/performance trade-offs.

Required Qualifications

• B.E./B.Tech or M.E./M.Tech in Mechanical Engineering, Mechatronics, or a related field.
• 5–10 years of hands-on mechanical/mechatronic design experience, with at least 2–3 years in medical device or SPM product development.
• Demonstrated experience taking a product from concept through prototype to design verification/validation.
• Required Skills & Experience

Design & Analysis

• Strong proficiency in 3D CAD (SolidWorks, Fusion) and GD&T/tolerance-stack analysis.
• Working knowledge of FEA for structural/static load verification.
• Experience sizing motors, linear/rotary actuators, gearboxes, and drive systems for force, torque, and speed requirements.
• Experience with multi-axis motion systems and precision positioning mechanisms.

Regulatory / Standards

• Working familiarity with medical device safety standards (e.g. the IEC 60601 series) applicable to electromechanical devices, including general safety requirements and any relevant particular/collateral standards for the product category.
• Experience working within ISO 13485 design-control processes (design inputs/outputs, verification & validation, DHF/DMR documentation).
• Familiarity with ISO 14971 risk management as it applies to mechanical hazards.

Prototyping & Testing

• Hands-on experience building and testing functional prototypes (mechanical + electromechanical integration).
• Experience designing and executing verification protocols: load/impact tests, cyclic durability tests, stability tests, ingress-protection testing.

Technical Leadership

• Review CAD models, drawings, calculations, and design documentation.
• Establish organization/domain level engineering standards, best practices, and design guidelines for the team.
• Drive design reviews and technical decision-making.
• Support project planning, and risk management

Tools

• CAD: Preferred - SolidWorks / Fusion 360.
• Documentation: MS Office / Excel-based design-input and traceability registers.
• PLM/PDM tools (any) is a plus.

Preferred / Nice-to-Have

• Experience with autonomous or semi-autonomous robotic systems involving sensor- or vision-guided motion.
• Experience with mechanisms handling consumables or materials as part of device operation.
• Prior experience in a medical device startup or fast-paced product development environment.
• Patents or publications related to medical device or robotics design.

Soft Skills

• Strong ownership mindset — comfortable being the technical decisionmaker for mechanical design trade-offs.
• Clear written and verbal communication for cross-functional coordination (electronics, software, regulatory, QA).
• Ability to balance rigorous, standards-driven engineering with the speed needed in an early-stage product environment.