Design Quality Engineer 2
Smith+Nephew · Pune · onsite · Posted 68d ago
Undisclosed2–5 yrsfulltimeSourced from
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About this role
Job Summary
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living as the Design Quality Engineer you would be Reporting into the Quality Department, this role provides Quality Engineering support for Smith & Nephew New Product Development activities for Hardware/Software products in the Sports Medicine franchise. Works collaboratively with project team members to develop and manage project plans and activities related to new product development. Responsible for supporting the execution of design control and risk management activities in accordance with internal procedures and applicable standards/regulations.
What will you be doing - Risk management file development: Risk management planning, use/design/software FMEA, risk control and mitigation, verification of effectiveness (15%)
- Cross-functional NPD support: Quality input to user needs, design inputs, software requirements, specifications and design outputs including CTQ features (25%)
- Design verification, validation and usability testing; software/system V&V including protocol/use case development, test execution and report writing (25%)
- Development and release of engineering design documentation; support design reviews and design history file compilation/audit activities (10%)
- Manufacturing quality activities including MSA, incoming inspection, control plans, process summaries and process FMEA (5%)
- Regulatory submission preparation and audit/inspection support (10%)
Education: B.S. in engineering or technically related field
What will you need to be successful - Risk Management per ISO 14971 (preferred)
- Medical device software development per IEC 62304 (preferred)
- ISO 13485 (preferred)
- Time management, multi-project planning
- Effective cross-functional collaboration
- Written/oral communication skills
- Accountability
- 2-5 years Quality Engineering experience in Medical Device or comparable regulated industry
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Engineering DesignAuditingISO 13485test executionCTQQuality EngineeringNew Product DevelopmentRisk Managementtime managementProject Planning
About Smith+Nephew
Smith+Nephew
Medical Equipment
3k+
employees
1856
170 years old
Pune, Maharashtra
India
₹10.2L PA avg
Avg at Smith+Nephew
About
Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration and replacement of soft and hard tissue.
Industries
Medical EquipmentHealthcareIT Services & ConsultingAccounting & Auditing
Employee ratings
10 reviews
4.1/ 5
Culture
3.9
Career growth
3.3
Work-life
4.0
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