Senior Staff Engineer - Medical Device Design

Stryker India Private Limited; Gurugram District; Hybrid; INR 1,500,000 - 3,000,000; Full time

Job summary

Stryker India Private Limited in Gurugram is seeking a Staff Engineer to independently research, design, develop, modify and verify components and subsystems for medical devices. You will translate user needs into design inputs and produce complex system-level designs with guidance.

You will mentor peers on design controls, FMEA, risk management, and QA procedures, collaborate across R&D, Quality, Manufacturing, Regulatory and Marketing to drive project success and deliver high-quality results

Qualifications

• Bachelor of Science in Engineering (Mechanical, Biomedical) with 4+ years of experience.
• Experience in research, design, development and verification of mechanical/electro-mechanical assemblies.
• Knowledge of design controls and risk management per QMS standards.

Responsibilities

• Research, design, develop, modify, and verify components and subsystems for medical devices.
• Translate user needs into design inputs and system-level designs.
• Lead documentation like the Design History File and apply design controls and risk management.
• Collaborate with R&D, Quality, Manufacturing, Regulatory, Marketing and PM to ensure project success.
• Mentor others in industry standards and test strategies.

Skills

DFM principles

Engineering drawings

GD&T

CAE tools

Mechanical design

Team communication

Education

B.S. in Engineering (Mechanical/Biomedical)

Tools

CAD software

CAE tools

Job description

Staff Engineer Work Flexibility: Hybrid

What you will do:

• Independently research, design, develop, modify, and verify components, modules and sub-systems for medical devices and translate user needs to design inputs/ specifications and produce complex system level designs with some guidance.
• Conduct or design advanced prototyping and testing and analyze and correct complex product design issues using independent judgment
• Advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings and apply detailed knowledge of clinical procedures to author design inputs
• Support Voice of Customer sessions internally and with clinicians and demonstrate developing financial acumen
• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
• Lead creation and refinement of engineering documentation, such as the Design History file and follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System
• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
• Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology
• Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process
• Deliver high quality results with passion, energy and drive to meet business priorities and collaborate with cross-functional teams to build partnership to achieve business objectives

What you will need- Required skills- Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 4+ years of work experience Experience- 7 years - 10 years

Preferred Qualifications-

• Strong technical ability to develop and optimize designs for mechanical / electro-mechanical assemblies incorporating DFM principles
• Strong technical ability in creating engineering drawings, models, applying GD&T and CAE tool
• Adept at applying knowledge of materials and manufacturing processes to product design
• Ability to communicate moderate complexity plans and technical information to team members

Travel Percentage: None Experience Level Senior Level