AXISCADES is a $100M Engineering Design firm with 2000+ engineers who are passionate about integrated solutions in mechanical, electrical and embedded engineering space. We specialize in providing engineering services and solutions to MNCs across the world.
Founded in 2005 in the India, we have rapidly established a strong customer base including those from the Aerospace, Defense, Auto, Heavy Engineering and now in Medical Device sectors; who come to us because of our flexible approach.
AXISCADES is a highly motivated and growing business operating within an energetic and friendly environment. We deliver the best and most appropriate technologies to whatever project is presented.
Remediation, New product development, Sustenance Engineering, Regulatory Compliance
Professional Experience Summary
Brings 8+ years of experience in Medical device domain with specialization in Remediation and Regulatory affairs.
Thorough understanding of FDA 21 CFR 820 / ISO 13485 guidelines
Regulatory compliance documentation
Orthopedic product design and development / product sustenance experience
Good understanding and implementation of design controls, change control management, engineering documentation Risk management
DHF Remediation (Mandatory)
Major roles and responsibilities
Carry out DHF remediation activities as per approved remediation plan.
Effective implementation and monitoring of risk management and risk analysis activities (FMEA) according to ISO 14971
Develop protocols and procedures.
Technical writing reports and technical justification.
Develop understanding in functional / system testing of medical devices.
Involved in investigating the root cause of product complaint, product nonconformance or process deviation and taking appropriate corrective/preventive actions
BE degree in Mechanical, Embedded or Electrical engineering from a reputed college
8+ years of Medical Device experience.
Ideally with an overall experience of 15+ years.
Ability to build a team of 100+ associate and managing them would be an added advantage.
Excellent attention to detail
Creative with innovative ideas
Strong verbal and written communication skills with an ability to deal with peers, leadership and customers alike
Excellent time and project management skills
Results orientated, self-motivated, resilient and able to perform under pressure.
Flexible and open-minded, whilst being able to challenge and be challenged.
commercially astute with an awareness of industry trends, new technologies and research areas.
Position is out of our Hyderabad office.
Salary:INR 12,00,000 – 22,00,000 P.A.
Industry:Medical Devices / Equipments
Functional Area:Engineering Design , R&D
Role Category:Quality Assurance & Quality Control-Compliance & Regulatory
Role:Quality Assurance & Quality Control-Manager
ISO 13485 Project Management Regulatory Compliance Regulatory Affairs Medical Devices New Product Development Change Control Engineering Services Design Development Product Design Remediation
Desired Candidate Profile:
Please refer to the Job description above
UG: B.Tech/B.E. – Any Specialization
PG:M.Tech – Any Specialization
AXISCADES Engineering Technology Ltd.
We are a focused High-Technology solutions company catering to the futuristic needs of Aerospace & Defense, Heavy Engineering, Automotive and Industrial Product sectors. Our proven technology products and services, coupled with industry best practices enable global OEMs create innovative, sustainable, safer and smarter products.
Our 1800+ innovators spread across the globe deliver technology solutions in Engineering Design, Software and Simulation, Embedded Systems, Mil-Aero, System Integration, Testing and Lifecycle Support areas.
Based in Bangalore, AXISCADES has offices worldwide including North America, Europe and Asia. With an unparalleled domain expertise, a passion to challenge the status quo, we are recognized as a preferred technology partner who can provide value across product lifecycle cycle from concept design to manufacturing support and after-market solutions.
Contact Company:Axis ITandT
Address:Ikon Towers ,Raheja Mind Space,Madhapur,Hitech City,Hyderabad-500081Hyderabad,Andhra Pradesh,India 500081