Design Quality Engineer 1

Smith & Nephew Gbs; Pune District; On-site; INR 300,000 - 600,000; Full time

Job summary

Smith+ Nephew is seeking a Design Quality Engineer to support quality engineering activities for hardware/software new product development. The role involves risk management, design controls, and cross-functional collaboration under supervision of senior quality staff.

You will assist with design verification/validation, generate design documentation, and contribute to design history file audits in a medical device context. 0–3 years of experience preferred.

Qualifications

• B.S. in engineering or a technically related field.
• 0–3 years quality engineering experience in medical device industry.
• Time management and collaboration with cross functional teams.

Responsibilities

• Support new product development and risk management for hardware/software products.
• Provide quality input to product user needs, design inputs, software requirements and design outputs.
• Support design verification testing, design validation and usability testing.
• Develop and release engineering design documentation, support design reviews and DHF compilation/audit activities.
• Support manufacturing quality activities including measurement systems analysis, incoming inspection, control plans and FMEA.
• Grow knowledge of design controls, risk management, testing, statistics and applicable standards.

Education

B.S. in engineering or a technically related field

Job description

Life Unlimited. At Smith+ Nephew, we design and manufacture technology that takes the limits off living as the Design Quality Engineer your role and responsibility for supporting Quality Engineering senior staff with New Product Development activities for hardware/software products. Works under direct supervision of senior quality staff to help project team members develop and manage project plans and activities. Under direction, support design control and risk management activities for assigned projects.

Responsibilities

• Under Quality Team supervision, support new product development and implementation of new hardware/software products via development of overall risk management file. Risk management planning, use/design/software FMEA, risk control and mitigation and verification of effectiveness. (15%)
• Under Quality Team supervision, support new product development of hardware/software products by participating on cross-functional core team. Provide quality input to product user needs, design inputs, software requirements, software detailed design specifications and design outputs including analysis/definition of critical to quality features. (20%)
• Under Quality Team supervision, support design verification testing, design validation and usability testing. Support as needed software and/or system verification/validation testing activities including protocol and use case development, test execution and report writing. (30%)
• Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities. (15%)
• Under Quality Team supervision support, manufacturing quality activities including measurement systems analysis, incoming inspection, control plans, process summaries and process FMEA. (5%)
• Improve knowledge of design controls, risk management, testing, statistics, Design Verification and Validation, Measurements Systems, applicable Quality System standards/regulations and business acumen. (15%)

Education and Experience

• Education: B.S. in engineering or a technically related field
• Experience: 0-3 years quality engineering experience in medical device industry

Requirements

• Time management, ability to plan and schedule multiple projects and tasks; effective collaboration with cross functional teams; effective written/oral communication skills; accountability