Mechanical Design Engineer

Job Title: Mechanical Designer

Location: Baner, Pune (5 days Work from Office)

Employment Type: Contingent Role (No Hybrid Option)

About Philips

Philips is a global leader in health technology, committed to improving lives through meaningful innovation. Within Philips, the Sleep & Respiratory Care (S&RC) business focuses on developing solutions that help people breathe easier and sleep better. Our products support patients, healthcare providers, and businesses worldwide by delivering intuitive, connected, and high-quality respiratory care solutions.

Position Summary

As a Mechanical Designer, you will be part of the Remediation, Relaunch, NPI (New Product Introduction), and Sustenance Mechanical Engineering team within R&D. You will contribute to the design, development, remediation, and regulatory compliance of ventilators and respiratory therapy accessories.

This role requires strong expertise in mechanical design, pneumatic systems, gas path components, and regulatory-driven product development in the medical device domain.

Key ResponsibilitiesSustenance & Remediation

• Lead sustenance engineering activities for respiratory products.

• Execute and support CAPA child tasks, MLD, and remediation activities.

• Support EU MDR and MDD compliance activities.

• Perform and document verification activities in laboratory environments.

• Lead Design History File (DHF) remediation including gap analysis, strategy planning, documentation updates, review, and release.

• Ensure DHF accountability for mechanical and mechatronic subsystems including:

  • Gas path systems

  • Valves and solenoids

  • Air, O₂, and pressure sensors

  • Manifolds

  • Patient interfaces

  • Filters, blowers, motors, and enclosures

Design & Development

• Conceive, design, analyze, and implement mechanical systems for ventilators and respiratory devices.

• Apply best practices in mechanical design, tolerance stack-up analysis, and modeling.

• Create component and assembly documentation using CAD tools.

• Develop requirements specifications, engineering analysis, drawings, validation plans, and test reports.

• Release components and assemblies to production and support production start-up.

Technical Leadership & Quality

• Lead Root Cause Analysis (RCA) using tools such as Fishbone and Why-Why analysis.

• Drive corrective and preventive actions to ensure effective CAPA closure.

• Perform FMEA, Risk Management (RMM), and engineering assessments.

• Mentor team members and review design documentation.

• Collaborate with PMG and Manufacturing Engineering during builds and production.

Manufacturing & Continuous Improvement

• Support troubleshooting of production issues.

• Stay updated with industry advancements and competitive technologies.

• Work cross-functionally to resolve issues during sample builds and mass production.

Product Coverage

Support and execution responsibilities include:

• DS1

• DS2

• Trilogy EVO

• RDD

• Therapy accessories

• EU MDR compliance activities for the above product lines

Required Qualifications

• Bachelor’s or Master’s Degree in Mechanical or Mechatronics Engineering

• Minimum 8 years of experience in medical device design or similar regulated industries

• Experience in CPAP/BiPAP devices or medical gas delivery systems (preferred)

• Experience leading technical teams in product development

Technical Skills

• Strong knowledge of pneumatic systems (pressure & flow sensing)

• Design of low and medium pressure gas valves

• Experience with low-pressure gas blowers

• Computational Fluid Dynamics (CFD) knowledge

• Plastic injection molded part design

• ASME Y14.5 Dimensioning & Tolerancing

• Proficiency in CAD tools (Creo/Pro-E preferred)

• Familiarity with FDA quality systems (ISO 13485, 21 CFR Part 820 preferred)

• Experience with SAP, Windchill, MBSE tools, CITOL, Ansys Workbench (advantage)

Key Competencies

• Strong mechanical aptitude

• Customer-first mindset

• Structured problem-solving capability

• Effective written and verbal communication skills

• Organized, disciplined, and action-oriented approach