This individual will lead the Medical Device delivery team.

- Responsible for all Medical Device department operations including revenue targets and responding to Request for Information and Request for Proposals.

- Conceptualize products of conceptions and obtain ISO13485 certification. Product Prototyping, Pilot Assembly and Design Transfer to Production.

- Strong Medical Device Domain expertise and in-depth understanding of the opportunities in outsourcing market

- Build strong competency in Quality Assurance and Regulatory Affairs consulting. Compilation of product Technical File, Design History File, Discharge Monitoring Report for regulatory submissions.

- Provide technical guidance and Program Manage all medical device design and engineering projects and successfully deliver on time, within budget. By professionally managing customer scope and program risks with effective project planning, monitoring & delivery and decision making. Continuous monitoring of project progress/milestones and review with top management.

- Build solutions leveraging innovative technologies to address medical device pain points for target markets: Initially USA, India and later Europe. Interact with and develop eco-system partners: Regulatory, Hospitals, Doctors, Medical Industry Experts panel.

- Adequate understanding of ISO standards ISO13485, ISO14971, Medical Devices regulations FDA 510(k), Medical safety standard IEC 60601 and comply with them.

- Good knowledge through an FDA approval cycle and ISO13485 certification would be a added advantage.

- Associating to Quality Management System and product development process as per ISO13485 requirements.

Candidate Qualifications:

- BE degree in Mechanical, Embedded or Biomedical, engineering from a reputed college

- 15+ years relevant experience with last 8+ years in the Medical Device industry

- Possession of controlling influence to build a team of 200+ associate and managing them would be an added advantage

Candidate's Ability:

- 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.

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