IF MedTech Pvt Ltd | Product Development Officer

2 weeks ago

navi mumbai, India IF MedTech Pvt Ltd Full time
Job description
At IF MedTech, we are dedicated to revolutionizing healthcare through cutting-edge medical device design,
development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering,
business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in
our mission to drive innovation and make a global impact in the medical technology sector.
Responsibilities:
Act as the central point of contact for product realization activities across all engineering disciplines (mechanical, electrical, software, etc.) and design disciplines.
Ensure all design and development activities align with the project timeline and ISO 13485 requirement
Coordinate product development activities to meet ISO 13485 and other relevant medical device regulations
Lead risk management processes, including Design Failure Modes and Effects Analysis (DFMEA) and Process Failure Modes and Effects Analysis (PFMEA)
Develop System design, product architecture for the products
Oversee the preparation, review, and control of all design and development documentation, including design history files, technical files, and other regulatory submissions
Ensure timely documentation updates during product lifecycle phases and audits.
Additionally liaise with Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain teams to ensure seamless product development and launch
Perform product integration, testing, and troubleshooting.
Maintain detailed technical documentation for system architecture, designs, and code.
Participate in reviews, providing and receiving constructive feedback for continuous improvement.
Promote knowledge sharing and best practices through internal training, demos, and participation in external industry events.
Qualifications and Skills Requirements:
Bachelor’s degree in Engineering (Mechanical, Electrical, Electronics, Instrumentation or Biomedical) or a related technical field.
Minimum 3 years of experience in overall product development within the medical device industry.
Experience coordinating cross-functional teams in a regulated environment (preferably ISO 13485).
Strong communication and teamwork skills.
Detail-oriented with a focus on quality and compliance.
Should be aware of the ISO 13485 work environment.
Knowledge of risk management of ISO 14971 is an added advantage.
Candidate should be able to understand the system architecture
Ability to diagnose issues in development and devise appropriate solutions.
Knowledge of mechanical, electrical, and electronics systems.
Knowledge of materials used in medical devices, especially biocompatible and durable materials.
Ability to design devices that are easily manufacturable at scale.
Skills in creating prototypes and iterative testing to refine designs.
Join IF MedTech to drive innovation in healthcare technology and develop solutions that transform lives worldwide

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