Senior Design Engineer

Stryker; Gurugram District; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Stryker in Gurgaon, India, seeks a Mechanical Design Engineer to lead end-to-end development of medical device components and systems. You will own design from concept to launch, perform analyses, and ensure quality across DHF/DMR, BOMs, and labeling, while coordinating with cross-functional teams.

You will apply GD&T, DFM/DFA, and engineering change processes, supporting V&V, regulatory compliance, and manufacturing transfer for robust, cost-effective solutions.

Qualifications

• Bachelor’s degree in mechanical engineering.
• 4+ years of mechanical design and product development experience.
• Expertise in Creo Parametric with 3D modelling and drawings; GD&T.
• Knowledge of Design for Manufacturing and Assembly (DFM/DFA).
• Experience with engineering change management processes.

Responsibilities

• Lead design and development of mechanical components and systems for medical devices across lifecycle.
• Own engineering change management activities with cross-functional coordination.
• Translate needs into engineering requirements and system designs; perform analyses.
• Prepare DHF, DMR, BOMs, labelling, IFUs, and design records to regulatory and quality standards.
• Create 3D models and drawings using CAD; apply GD&T per industry standards.
• Plan and execute V&V activities; develop protocols, test, analyze data, and report results.
• Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, Supply Chain, and Operations.
• Support manufacturing transfer, product launches, cost reduction, and continuous improvements.

Skills

Mechanical design

NPD

GD&T

Engineering change management

Education

Bachelor’s degree in mechanical engineering

Tools

Creo Parametric

Windchill

Job description

• Lead the design and development of mechanical components and systems for medical devices, executing end-to-end new product development (NPD) across all product lifecycle phases—from concept generation and detailed design through verification, validation, and product launch.
• Own engineering change management activities, including impact assessments, documentation, approvals, and implementation, while coordinating with cross-functional stakeholders to ensure timely execution.
• Translate user, clinical, and business needs into engineering requirements, product specifications, and system-level designs. Perform engineering analyses, including simulations, engineering calculations, tolerance analysis, and statistical evaluations, to optimize product performance, quality, and reliability.
• Prepare and maintain comprehensive engineering documentation, including Design History Files (DHF), Device Master Records (DMR), engineering drawings, Bills of Materials (BOMs), labelling, Instructions for Use (IFUs), engineering specifications, and design records, ensuring compliance with company standards, regulatory requirements, and quality system procedures.
• Prepare and maintain detailed 3D models, engineering drawings, schematics, and specifications using CAD software, preferably Creo Parametric, while applying GD&T in accordance with industry standards.
• Collaborate with laboratory teams to plan and execute verification and validation (V&V) activities, including test method development, protocol preparation, test execution, data analysis, and technical reporting.
• Partner effectively with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, Clinical, Marketing, Supply Chain, and Operations to deliver projects within scope, quality, cost, and schedule.
• Support prototype development, design verification, design validation, manufacturing transfer, product launches, value engineering, cost reduction initiatives, and continuous product improvements.
• Apply Design for Manufacturing and Assembly (DFM/DFA) principles, materials selection, and manufacturing process knowledge to develop robust, manufacturable, and cost-effective designs.
• Lead or contribute to technical design reviews and collaborate with global stakeholders, suppliers, vendors, and subject matter experts (SMEs) to resolve technical challenges and drive project success.
• Ensure compliance with applicable quality and regulatory requirements, including Design Controls, Risk Management, and company engineering processes throughout the product development lifecycle.

Role and Responsibilities:

• Lead the design and development of mechanical components and systems for medical devices, executing end-to-end new product development (NPD) across all product lifecycle phases—from concept generation and detailed design through verification, validation, and product launch.
• Own engineering change management activities, including impact assessments, documentation, approvals, and implementation, while coordinating with cross-functional stakeholders to ensure timely execution.
• Translate user, clinical, and business needs into engineering requirements, product specifications, and system-level designs. Perform engineering analyses, including simulations, engineering calculations, tolerance analysis, and statistical evaluations, to optimize product performance, quality, and reliability.
• Prepare and maintain comprehensive engineering documentation, including Design History Files (DHF), Device Master Records (DMR), engineering drawings, Bills of Materials (BOMs), labelling, Instructions for Use (IFUs), engineering specifications, and design records, ensuring compliance with company standards, regulatory requirements, and quality system procedures.
• Prepare and maintain detailed 3D models, engineering drawings, schematics, and specifications using CAD software, preferably Creo Parametric, while applying GD&T in accordance with industry standards.
• Collaborate with laboratory teams to plan and execute verification and validation (V&V) activities, including test method development, protocol preparation, test execution, data analysis, and technical reporting.
• Partner effectively with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, Clinical, Marketing, Supply Chain, and Operations to deliver projects within scope, quality, cost, and schedule.
• Support prototype development, design verification, design validation, manufacturing transfer, product launches, value engineering, cost reduction initiatives, and continuous product improvements.
• Apply Design for Manufacturing and Assembly (DFM/DFA) principles, materials selection, and manufacturing process knowledge to develop robust, manufacturable, and cost-effective designs.
• Lead or contribute to technical design reviews and collaborate with global stakeholders, suppliers, vendors, and subject matter experts (SMEs) to resolve technical challenges and drive project success.
• Ensure compliance with applicable quality and regulatory requirements, including Design Controls, Risk Management, and company engineering processes throughout the product development lifecycle.

Required Skills

• Bachelor’s degree in mechanical engineering; 4+ years of experience in mechanical design and product development.
• Experience- 5 years- 7 years;
• Expertise in Creo Parametric with hands-on experience in 3D modelling, drafting, engineering drawings, and application of GD&T; experience designing mechanical components, including machined, sheet metal, molded, or cast parts.
• Knowledge of Design for Manufacturing and Assembly (DFM/DFA), materials selection, manufacturing processes, engineering calculations, tolerance analysis, and thermal analysis/simulation.
• Understanding of engineering change management processes.

Preferred Qualifications

• Experience with Product Lifecycle Management (PLM/PDM) systems, preferably Windchill.
• Working knowledge of verification and validation methodologies, root cause analysis, DFMEA/PFMEA, and statistical analysis tools.
• Exposure to regulated product development in industries such as medical devices, consumer electronics, industrial equipment, automotive, or aerospace.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.